Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA
Sponsor
Navidea Biopharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02865434
Collaborator
(none)
39
1
11
17
2.3
Study Details
Study Description
Brief Summary
Prospective, open-label, multicenter, dose escalation, safety with pharmacokinetics (PK) and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
A Manocept Platform prospective, open-label, multicenter, dose escalation, safety with PK and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging. All subjects will receive IV administration at one of 3 mass doses: 50 µg, 200 µg, or 400 µg. Within each mass dose group, subjects will receive Tc 99m tilmanocept labeled with one of 3 radiolabel doses: 1 mCi, 5 mCi, or 10 mCi.
All subjects will have a whole body planar SPECT scan. Subjects enrolled in Groups 1-9 will receive a whole body and planar hands scan followed by SPECT/CT scans on areas of interest post injection at 60 minutes ± 15 minutes and 180 minutes ± 15 minutes. Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed at 4 specified time points post injection: 15 ± 5 minutes, 60 ± 15 minutes, 180 ± 15 minutes and 18-20 hours. Planar hand scans will be collected at 60 ± 15 minutes and 180 ± 15 minutes post-injection. PK blood sampling will be performed before injection (within 15 minutes), immediately following injection (within 5 minutes) and at each scanning timepoint. Dosimetry tests will be performed at each scanning timepoint. PK of urine will be assessed through counts of the bladder wall obtained from cumulative quantitative planar imaging from radiation dosimetry.
Study Design
Study Type:
Interventional
Actual Enrollment
:
39 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection and Skeletal Joint Imaging With SPECT in Subjects With Active Rheumatoid Arthritis (RA) and Healthy Controls
Actual Study Start Date
:
Jan 1, 2017
Actual Primary Completion Date
:
Jun 1, 2018
Actual Study Completion Date
:
Jun 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 (RA) Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). |
Drug: Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Names:
Procedure: SPECT Imaging (60 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.
Procedure: SPECT Imaging (180 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.
Procedure: Planar Image with both Hands in Field of View
Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.
|
| Experimental: Group 2 (RA) Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). |
Drug: Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Names:
Procedure: SPECT Imaging (60 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.
Procedure: SPECT Imaging (180 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.
Procedure: Planar Image with both Hands in Field of View
Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.
|
| Experimental: Group 3 (RA) Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). |
Drug: Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Names:
Procedure: SPECT Imaging (60 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.
Procedure: SPECT Imaging (180 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.
Procedure: Planar Image with both Hands in Field of View
Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.
|
| Experimental: Group 4 (RA) Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). |
Drug: Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Names:
Procedure: SPECT Imaging (60 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.
Procedure: SPECT Imaging (180 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.
Procedure: Planar Image with both Hands in Field of View
Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.
|
| Experimental: Group 5 (RA) Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). |
Drug: Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Names:
Procedure: SPECT Imaging (60 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.
Procedure: SPECT Imaging (180 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.
Procedure: Planar Image with both Hands in Field of View
Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.
|
| Experimental: Group 6 (RA) Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). |
Drug: Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Names:
Procedure: SPECT Imaging (60 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.
Procedure: SPECT Imaging (180 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.
Procedure: Planar Image with both Hands in Field of View
Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.
|
| Experimental: Group 7 (RA) Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). |
Drug: Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Names:
Procedure: SPECT Imaging (60 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.
Procedure: SPECT Imaging (180 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.
Procedure: Planar Image with both Hands in Field of View
Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.
|
| Experimental: Group 8 (RA) Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). |
Drug: Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Names:
Procedure: SPECT Imaging (60 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.
Procedure: SPECT Imaging (180 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.
Procedure: Planar Image with both Hands in Field of View
Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.
|
| Experimental: Group 9 (RA) Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). |
Drug: Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Other Names:
Procedure: SPECT Imaging (60 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.
Procedure: SPECT Imaging (180 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.
Procedure: Planar Image with both Hands in Field of View
Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.
|
| Experimental: Group 10 (Healthy Controls) Group 10 will receive Tc99m-tilmanocept at the MTD via IV injection, Whole body planar SPECT imaging (15 Minutes post-injection) , Whole body planar SPECT imaging (60 minutes post-injection) , Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection), Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection), Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection) , Blood Collection for PK Testing (15 minutes post injection) , Blood Collection for PK Testing (60 minutes post injection) , Blood Collection for PK Testing (180 minutes post injection) , and Blood Collection for PK Testing (18-20 hours post injection). |
Procedure: Whole body planar SPECT imaging (15 Minutes post-injection)
Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 15 minutes post-injection for dosimetry.
Procedure: Whole body planar SPECT imaging (60 Minutes post-injection)
Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 60 minutes post-injection for dosimetry.
Procedure: Whole body planar SPECT imaging (180 Minutes post-injection)
Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 180 minutes post-injection for dosimetry.
Procedure: Whole body planar SPECT imaging (18-20 Hours post-injection)
Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 18-20 Hours post-injection for dosimetry.
Procedure: Blood Collection for PK Testing (15 Mins Before Injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis within 15 minutes prior to administration of Tc 99m tilmanocept
Procedure: Blood Collection for PK Testing (after injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis immediately following administration of Tc 99m tilmanocept (00:00)
Procedure: Blood Collection for PK Testing (15 minutes post injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 15 ± 5 minutes post injection of Tc 99m tilmanocept
Procedure: Blood Collection for PK Testing (60 minutes post injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 60 ± 15 minutes post injection of Tc 99m tilmanocept
Procedure: Blood Collection for PK Testing (180 minutes post injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 180 ± 15 minutes post injection of Tc 99m tilmanocept
Procedure: Blood Collection for PK Testing (18-20 hours post injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 18-20 hours post injection of Tc 99m tilmanocept
Procedure: Planar Image with both Hands in Field of View
Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.
|
| Experimental: Group 11 (RA) Group 11 will receive Tc99m-tilmanocept at the MTD via IV injection, Whole body planar SPECT imaging (15 Minutes post-injection) , Whole body planar SPECT imaging (60 minutes post-injection) , Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection), Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection), Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection) , Blood Collection for PK Testing (15 minutes post injection) , Blood Collection for PK Testing (60 minutes post injection) , Blood Collection for PK Testing (180 minutes post injection) , and Blood Collection for PK Testing (18-20 hours post injection). |
Procedure: Whole body planar SPECT imaging (15 Minutes post-injection)
Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 15 minutes post-injection for dosimetry.
Procedure: Whole body planar SPECT imaging (60 Minutes post-injection)
Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 60 minutes post-injection for dosimetry.
Procedure: Whole body planar SPECT imaging (180 Minutes post-injection)
Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 180 minutes post-injection for dosimetry.
Procedure: Whole body planar SPECT imaging (18-20 Hours post-injection)
Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 18-20 Hours post-injection for dosimetry.
Procedure: Blood Collection for PK Testing (15 Mins Before Injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis within 15 minutes prior to administration of Tc 99m tilmanocept
Procedure: Blood Collection for PK Testing (after injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis immediately following administration of Tc 99m tilmanocept (00:00)
Procedure: Blood Collection for PK Testing (15 minutes post injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 15 ± 5 minutes post injection of Tc 99m tilmanocept
Procedure: Blood Collection for PK Testing (60 minutes post injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 60 ± 15 minutes post injection of Tc 99m tilmanocept
Procedure: Blood Collection for PK Testing (180 minutes post injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 180 ± 15 minutes post injection of Tc 99m tilmanocept
Procedure: Blood Collection for PK Testing (18-20 hours post injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 18-20 hours post injection of Tc 99m tilmanocept
Procedure: Planar Image with both Hands in Field of View
Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.
|
Outcome Measures
Primary Outcome Measures
- Incidence of Adverse Drug Reaction [From Enrollment to termination, up to 53 days]
Number of participants that experienced pharmacologic activity or ADR in each dose group.
Secondary Outcome Measures
- Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging [For Groups 1-9, 60 ± 15 min or 180 ± 15 minute post injection planar and SPECT/CT images are used]
Tc 99m Tilmanocept localization is defined as the visually (i.e., qualitatively) determined binary categorization of Tc 99m tilmanocept activity in a given DAS28 joint. The purpose of the visual assessments is to obtain dichotomized classifications of tracer uptake (herein referenced as 'localization') on planar images. Per subject localization rate is the number of subjects with at least one localized DAS28 joint per number of subjects in the analysis population.
- Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints [Whole-body planar scan at 60 ± 15 and 180 ± 15 minutes post Tc 99m tilmanocept administration with a duration of approximately 25 to 30 minutes at each timepoint.]
Per joint (clinically RA-identified) joint localization rate of Tc 99m tilmanocept is defined as the number of localized joints per number of joints from subjects in the analysis population Groups 1-9 using SPECT imaging.
- Concordance [Qualitative (i.e., visual) assessments of planar images were acquired at the 60 ± 15-minute and 180 ± 15-minute timepoints in Groups 1-9.]
Concordance is defined as the relationship or the presence of Tc99m localization in anatomical areas of active RA defined by clinical symptomology (defined as joint swelling (SJC) and/or tenderness (TJC) during the screening DAS28 evaluation).
- Localization Intensity [Post-injection imaging at 60±15 and 180±15 min]
Localization intensity is defined as the presence of Tc99m in each DAS28 joint and is output in tilmanocept uptake value (TUV) units, as computed using the following equation: 〖TUV〗=ROI/BRAIN×100 where ROI = decay-corrected avg voxel intensity of the joint ROI and BRAIN =decay-corrected avg voxel intensity of the brain RR
- Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA [Imaging taken 60 ± 15 min and 180 ± 15 min post-injection]
Per subject localization rate of Tc 99m tilmanocept in areas other than RA is defined as the number of subjects with at least one localized DAS28 joint per number of subjects in the analysis population.
- Maximum Observed Concentration (Cmax) [15 minutes prior to administration. Immediately after administration. 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration]
Maximum observed concentration (Cmax) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.
- Time to Cmax (Tmax) [Radioactivity was quantitated at each time point -15 mins prior to administration• Immediately after administration •15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post admi]
Time to Cmax (tmax) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.
- Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measureable Concentration (AUC0-t) [Hour 0 to hour 18-20, with time points immediately post injection, 0.25 hr, 1 hr, 3 hr and 18-20 hr after injection]
Area under the concentration-time curve (AUC) from Hour 0 to the last measureable concentration (18 to 20 hours) (AUC0-t) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.
- AUC Extrapolated to Infinity [15 mins prior to administration • Immediately after administration • 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration]
AUC extrapolated to infinity will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.
- Apparent Terminal Elimination Rate Constant (Z) [15 mins prior to administration • Immediately after administration • 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration]
Apparent terminal elimination rate constant (Z) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.
- Apparent Terminal Elimination Half-life (t1/2) [15 mins prior to administration • Immediately after administration • 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration]
Apparent terminal elimination half-life (t1/2) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.
- Radiation Dosimetry of Tc 99m Tilmanocept [Planar images were taken 15 ± 5 minutes, 60 ± 5 minutes, 180 ± 5 minutes, 18 to 20 hours after Tc 99m tilmanocept administration and processed in accordance with the NAV3-21 protocol endpoints using established dosimetry software.]
Mean total radiation dose per organ (mSv/MBq) in HC females, HC males, females with active RA, and males with active RA. Results were obtained at the subject level from Hybrid Dosimetry™ Version 2.8.3 and OLINDA/EXM® Version 2.1RC93 in accordance with NAV3-21 Protocol Amendment 6. The Hybrid Dosimetry™ function provides an efficient way to generate kinetic data for selected organs via regions of interest (ROI) drawing. From this data, residence times are calculated and transferred to OLINDA/EXM®, which generates absorbed dose tables using the MIRD methodology.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
ALL SUBJECTS:
-
The subject has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) authorization before the initiation of any study-related procedures.
-
Has a negative urine drug screening for illicit or unprescribed drugs suggestive of drug abuse.
-
All subjects shall be ≥18 years of age at the time of consent.
CONTROL SUBJECTS:
- The subject is deemed to be clinically free of any inflammatory disease (s) and has not experienced joint pain for at least 4 weeks prior to the consent date.
ACTIVE RHEUMATOID ARTHRITIS SUBJECTS:
-
The subject has moderate to severe RA as determined by the 2010 ACR/EULAR (score of ≥ 6/10).
-
The subject has a DAS28 of ≥ 3.2 (includes the Erythrocyte Sedimentation Rate [ESR] test and Visual Analog Scale [VAS]) .
-
If the subject is receiving methotrexate, they have been at a stable dose for > 4 weeks prior to the Baseline Visit 2 (Day 1).
-
If the subject is receiving biologic therapy, they have been at a stable dose > 8 weeks prior to the Baseline Visit 2 (Day 1).
-
If the subject is receiving NSAIDS or oral corticosteroids, the dose has been at a stable dose for > 4 weeks prior to the Baseline Visit 2 (Day 1). The corticosteroid dose should be ≤ 10mg/day of prednisone or an equivalent steroid dose.
Exclusion Criteria:
-
The subject is pregnant or lactating.
-
The subject size or weight is not compatible with imaging per the investigator.
-
The subject has had or is currently receiving radiation therapy or chemotherapy for a condition other than rheumatoid arthritis.
-
The subject has renal insufficiency as demonstrated by serum creatinine clearance of < 60 mL/min.
-
The subject has hepatic insufficiency as demonstrated by ALT or AST greater than two times the upper limit of normal.
-
The subject has a chronic or persistent infection or has any condition that would, in the opinion of the examining physician, preclude their participation.
-
The subject has a known allergy to or has had an adverse reaction to dextran exposure.
-
The subject has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration.
-
The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kettering Medical Center | Kettering | Ohio | United States | 45429 |
Sponsors and Collaborators
- Navidea Biopharmaceuticals
Investigators
- Study Director: Micheal Blue, MD, Navidea Biopharmaceuticals
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT02865434
Other Study ID Numbers:
- NAV3-21
First Posted:
Aug 12, 2016
Last Update Posted:
Aug 12, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Period Title: Overall Study | |||||||||||
| STARTED | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 6 | 6 |
| COMPLETED | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Total of all reporting groups |
| Overall Participants | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 6 | 6 | 39 |
| Age (Count of Participants) | ||||||||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
6
100%
|
6
100%
|
39
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | ||||||||||||
| Mean (Standard Deviation) [years] |
55.3
(8.14)
|
58.7
(4.73)
|
55.0
(11.16)
|
46.3
(9.87)
|
50.7
(12.74)
|
52.0
(12.53)
|
53.3
(5.69)
|
56.3
(8.14)
|
58.0
(3.00)
|
32.0
(12.55)
|
55.0
(11.16)
|
54.2
(8.99)
|
| Sex: Female, Male (Count of Participants) | ||||||||||||
| Female |
2
66.7%
|
2
66.7%
|
3
100%
|
2
66.7%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
50%
|
3
50%
|
30
76.9%
|
| Male |
1
33.3%
|
1
33.3%
|
0
0%
|
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
3
50%
|
3
50%
|
9
23.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
33.3%
|
3
7.7%
|
| Not Hispanic or Latino |
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
2
66.7%
|
3
100%
|
3
100%
|
3
100%
|
6
100%
|
4
66.7%
|
36
92.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
1
33.3%
|
1
16.7%
|
0
0%
|
4
10.3%
|
| White |
2
66.7%
|
2
66.7%
|
2
66.7%
|
3
100%
|
3
100%
|
1
33.3%
|
2
66.7%
|
2
66.7%
|
1
33.3%
|
3
50%
|
5
83.3%
|
26
66.7%
|
| More than one race |
1
33.3%
|
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
2
66.7%
|
0
0%
|
1
33.3%
|
1
33.3%
|
2
33.3%
|
1
16.7%
|
9
23.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||||||||||
| United States |
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
6
100%
|
6
100%
|
39
100%
|
| BMI (kg/m^2) [Mean (Standard Deviation) ] | ||||||||||||
| Mean (Standard Deviation) [kg/m^2] |
24.4
(7.4)
|
29.8
(3.10)
|
33.5
(7.5)
|
29.5
(8.47)
|
39.2
(11.75)
|
39.3
(8.80)
|
29.2
(4.76)
|
34.5
(4.62)
|
33.5
(6.37)
|
27.3
(7.74)
|
33.5
(7.5)
|
32.7
(7.72)
|
Outcome Measures
| Title | Incidence of Adverse Drug Reaction |
|---|---|
| Description | Number of participants that experienced pharmacologic activity or ADR in each dose group. |
| Time Frame | From Enrollment to termination, up to 53 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Measure Participants | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 6 | 6 |
| Count of Participants [Participants] |
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
6
100%
|
6
100%
|
| Title | Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging |
|---|---|
| Description | Tc 99m Tilmanocept localization is defined as the visually (i.e., qualitatively) determined binary categorization of Tc 99m tilmanocept activity in a given DAS28 joint. The purpose of the visual assessments is to obtain dichotomized classifications of tracer uptake (herein referenced as 'localization') on planar images. Per subject localization rate is the number of subjects with at least one localized DAS28 joint per number of subjects in the analysis population. |
| Time Frame | For Groups 1-9, 60 ± 15 min or 180 ± 15 minute post injection planar and SPECT/CT images are used |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects enrolled in Groups 10 and 11 received whole-body planar scans following Tc99 administration for PK and dosimetry analyses only. |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc99m at the MTD via IV injection. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection) Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc99m-tilmanocept at the MTD via IV injection. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection) Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Measure Participants | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 0 | 0 |
| 60 ± 15 min |
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
||
| 180 ± 15 min |
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
| Title | Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints |
|---|---|
| Description | Per joint (clinically RA-identified) joint localization rate of Tc 99m tilmanocept is defined as the number of localized joints per number of joints from subjects in the analysis population Groups 1-9 using SPECT imaging. |
| Time Frame | Whole-body planar scan at 60 ± 15 and 180 ± 15 minutes post Tc 99m tilmanocept administration with a duration of approximately 25 to 30 minutes at each timepoint. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Groups 10 & 11 were not included in the population these endpoints were evaluated for. |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Measure Participants | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 0 | 0 |
| Measure Joint | 23 | 82 | 45 | 32 | 13 | 52 | 16 | 24 | 29 | 0 | 0 |
| Joint localization at 1 hr |
7
|
40
|
25
|
12
|
5
|
28
|
5
|
13
|
12
|
0
|
0
|
| Joint localization at 3 hr |
16
|
42
|
20
|
20
|
8
|
24
|
11
|
11
|
17
|
| Title | Concordance |
|---|---|
| Description | Concordance is defined as the relationship or the presence of Tc99m localization in anatomical areas of active RA defined by clinical symptomology (defined as joint swelling (SJC) and/or tenderness (TJC) during the screening DAS28 evaluation). |
| Time Frame | Qualitative (i.e., visual) assessments of planar images were acquired at the 60 ± 15-minute and 180 ± 15-minute timepoints in Groups 1-9. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Groups 10 & 11 were not included in the population these endpoints were evaluated for. |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Measure Participants | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 0 | 0 |
| Measure Joint | 59 | 64 | 44 | 78 | 62 | 60 | 67 | 97 | 63 | 0 | 0 |
| Concordance at 1 hr |
21
|
32
|
17
|
39
|
31
|
29
|
30
|
53
|
35
|
0
|
0
|
| Concordance at 3 hr |
38
|
32
|
27
|
39
|
31
|
31
|
37
|
44
|
28
|
0
|
0
|
| Title | Localization Intensity |
|---|---|
| Description | Localization intensity is defined as the presence of Tc99m in each DAS28 joint and is output in tilmanocept uptake value (TUV) units, as computed using the following equation: 〖TUV〗=ROI/BRAIN×100 where ROI = decay-corrected avg voxel intensity of the joint ROI and BRAIN =decay-corrected avg voxel intensity of the brain RR |
| Time Frame | Post-injection imaging at 60±15 and 180±15 min |
Outcome Measure Data
| Analysis Population Description |
|---|
| Groups 1-9 only. Groups 10 and 11 were not included. |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Measure Participants | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 0 | 0 |
| Measure Joints | 28 | 28 | 28 | 28 | 28 | 28 | 28 | 28 | 28 | 0 | 0 |
| 60 ± 15 min L Shoulder |
138.9
(27.35)
|
193.2
(85.82)
|
188.4
(92.19)
|
177.9
(64.22)
|
135.0
(31.90)
|
146.1
(35.54)
|
177.6
(19.37)
|
269.3
(238.60)
|
152.7
(37.92)
|
||
| 60 ± 15 min R Shoulder |
156.1
(19.95)
|
222.6
(113.08)
|
181.2
(73.69)
|
179.5
(65.66)
|
145.7
(26.65)
|
140.8
(12.82)
|
180.1
(18.23)
|
293.8
(255.64)
|
184.8
(17.51)
|
||
| 60 ± 15 min L Elbow |
68.3
(3.38)
|
NA
(NA)
|
76.6
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
104.7
(22.16)
|
82.3
(15.04)
|
72.1
(4.87)
|
||
| 60 ± 15 min R Elbow |
87.4
(4.94)
|
88.4
(NA)
|
NA
(NA)
|
94.7
(19.29)
|
76.5
(NA)
|
NA
(NA)
|
110.3
(14.34)
|
101.1
(16.15)
|
77.3
(13.07)
|
||
| 60 ± 15 min L Wrist |
292.7
(96.46)
|
415.9
(55.06)
|
332.7
(168.46)
|
416.1
(202.00)
|
246.3
(109.90)
|
358.4
(136.55)
|
387.4
(157.13)
|
472.9
(386.02)
|
368.8
(146.85)
|
||
| 60 ± 15 min R Wrist |
387.6
(246.92)
|
420.9
(59.76)
|
351.3
(139.75)
|
458.5
(282.25)
|
271.9
(88.55)
|
432.4
(268.22)
|
465.5
(254.62)
|
492.0
(351.80)
|
337.6
(191.93)
|
||
| 60 ± 15 min L MCP1 |
192.2
(5.81)
|
299.2
(51.36)
|
203.1
(64.07)
|
230.2
(97.52)
|
222.9
(81.58)
|
186.0
(18.29)
|
241.4
(41.31)
|
250.7
(95.14)
|
326.9
(123.01)
|
||
| 60 ± 15 min L MCP2 |
175.1
(23.18)
|
394.3
(152.28)
|
318.7
(148.66)
|
243.8
(101.78)
|
177.0
(80.29)
|
167.6
(43.83)
|
333.5
(68.95)
|
323.6
(263.03)
|
248.3
(132.40)
|
||
| 60 ± 15 min L MCP3 |
187.1
(28.12)
|
408.7
(64.48)
|
259.4
(118.16)
|
228.7
(123.51)
|
206.7
(87.69)
|
187.9
(44.78)
|
286.5
(26.59)
|
324.0
(258.57)
|
270.5
(122.88)
|
||
| 60 ± 15 min L MCP4 |
181.0
(40.41)
|
374.9
(103.52)
|
204.7
(78.91)
|
225.3
(93.15)
|
214.8
(93.50)
|
185.5
(50.83)
|
253.1
(61.97)
|
240.9
(221.84)
|
211.7
(75.61)
|
||
| 60 ± 15 min L MCP5 |
141.9
(28.51)
|
323.4
(77.01)
|
159.4
(67.15)
|
207.1
(87.17)
|
206.5
(101.51)
|
166.2
(34.36)
|
236.1
(42.07)
|
220.3
(152.82)
|
220.9
(59.92)
|
||
| 60 ± 15 min R MCP1 |
238.0
(31.29)
|
310.8
(41.45)
|
230.0
(73.68)
|
261.1
(155.97)
|
254.9
(78.65)
|
226.3
(57.31)
|
261.6
(27.81)
|
354.4
(162.04)
|
349.4
(213.53)
|
||
| 60 ± 15 min R MCP2 |
231.7
(26.52)
|
405.4
(153.35)
|
285.8
(106.50)
|
295.1
(227.83)
|
188.6
(58.65)
|
272.7
(183.37)
|
286.7
(46.46)
|
269.6
(167.41)
|
286.1
(114.89)
|
||
| 60 ± 15 min R MCP 3 |
245.8
(19.43)
|
353.6
(45.80)
|
237.7
(135.01)
|
296.9
(156.42)
|
229.1
(72.37)
|
234.8
(122.53)
|
267.8
(44.47)
|
323.9
(288.11)
|
336.0
(158.66)
|
||
| 60 ± 15 min R MCP4 |
224.4
(20.27)
|
326.4
(59.57)
|
189.9
(102.96)
|
231.4
(147.10)
|
223.3
(78.82)
|
242.7
(143.34)
|
259.0
(62.48)
|
265.8
(137.12)
|
290.5
(133.03)
|
||
| 60 ± 15 min R MCP5 |
182.3
(4.68)
|
316.1
(109.30)
|
153.9
(85.85)
|
208.0
(140.89)
|
162.2
(53.15)
|
192.0
(69.35)
|
219.6
(86.83)
|
222.1
(117.16)
|
215.5
(103.57)
|
||
| 60 ± 15 min L PIP1 |
130.4
(5.02)
|
239.3
(91.26)
|
127.2
(48.94)
|
196.6
(98.77)
|
148.4
(53.25)
|
134.8
(21.00)
|
201.2
(113.75)
|
166.8
(100.57)
|
243.9
(14.08)
|
||
| 60 ± 15 min L PIP2 |
120.7
(14.68)
|
158.4
(55.78)
|
105.4
(49.80)
|
153.3
(72.08)
|
129.8
(55.88)
|
126.0
(17.08)
|
177.9
(18.887)
|
129.9
(41.93)
|
165.6
(46.37)
|
||
| 60 ± 15 min L PIP3 |
125.7
(7.78)
|
212.3
(93.24)
|
117.0
(58.62)
|
170.1
(105.66)
|
129.8
(65.39)
|
120.2
(12.47)
|
201.1
(48.49)
|
204.0
(160.22)
|
200.3
(85.58)
|
||
| 60 ± 15 min L PIP4 |
109.6
(8.41)
|
172.9
(20.07)
|
106.9
(43.54)
|
151.8
(56.55)
|
126.3
(58.40)
|
117.5
(24.73)
|
163.8
(53.06)
|
215.6
(152.95)
|
171.4
(75.27)
|
||
| 60 ± 15 min L PIP5 |
95.2
(14.68)
|
126.3
(38.80)
|
86.6
(23.94)
|
138.5
(89.37)
|
108.9
(66.64)
|
96.4
(13.92)
|
149.5
(54.15)
|
215.6
(183.50)
|
160.8
(36.56)
|
||
| 60 ± 15 min R PIP1 |
165.5
(6.81)
|
285.6
(51.59)
|
141.7
(71.45)
|
171.3
(71.34)
|
152.8
(48.86)
|
148.7
(6.24)
|
208.5
(39.27)
|
244.8
(154.04)
|
239.4
(74.89)
|
||
| 60 ± 15 min R PIP2 |
137.5
(12.17)
|
184.6
(33.97)
|
121.7
(61.52)
|
194.8
(97.92)
|
139.7
(56.90)
|
133.3
(49.95)
|
215.1
(35.17)
|
198.1
(144.14)
|
187.0
(77.42)
|
||
| 60 ± 15 min R PIP3 |
156.6
(6.02)
|
189.6
(18.21)
|
124.5
(74.14)
|
215.0
(127.88)
|
140.7
(30.08)
|
168.1
(95.49)
|
191.8
(43.07)
|
224.3
(141.68)
|
189.5
(44.79)
|
||
| 60 ± 15 min R PIP4 |
133.2
(19.03)
|
200.5
(83.90)
|
125.4
(99.16)
|
161.3
(93.41)
|
143.0
(53.77)
|
143.6
(57.59)
|
160.7
(50.81)
|
221.6
(161.97)
|
156.8
(47.62)
|
||
| 60 ± 15 min R PIP5 |
107.9
(13.12)
|
174.7
(59.35)
|
88.9
(54.01)
|
144.3
(66.00)
|
104.0
(33.68)
|
104.3
(29.19)
|
186.8
(36.75)
|
170.9
(91.39)
|
170.5
(103.26)
|
||
| 60 ± 15 min L Knee |
66.5
(17.79)
|
107.4
(38.98)
|
79.5
(18.89)
|
101.4
(23.40)
|
79.6
(15.84)
|
78.5
(32.65)
|
86.8
(14.06)
|
176.7
(170.34)
|
124.0
(16.81)
|
||
| 60 ± 15 min R Knee |
76.2
(23.25)
|
118.8
(50.05)
|
99.3
(36.85)
|
98.3
(22.13)
|
78.7
(14.07)
|
67.1
(8.62)
|
91.1
(14.44)
|
165.4
(174.57)
|
133.7
(22.82)
|
||
| 180 ± 15 min L Shoulder |
165.4
(54.95)
|
210.1
(89.77)
|
232.2
(116.41)
|
211.0
(81.71)
|
160.8
(55.63)
|
163.0
(37.4)
|
218.0
(67.76)
|
301.4
(254.58)
|
181.4
(66.68)
|
||
| 180 ± 15 min R Shoulder |
189.1
(51.36)
|
240.5
(118.56)
|
230.0
(81.69)
|
209.3
(86.04)
|
177.6
(54.82)
|
148.9
(12.60)
|
221.6
(59.4)
|
321.0
(237.86)
|
206.1
(41.31)
|
||
| 180 ± 15 min L Elbow |
71.8
(13.49)
|
NA
(NA)
|
76.2
(NA)
|
102.4
(49.11)
|
57.7
(NA)
|
NA
(NA)
|
94.6
(13.84)
|
101.2
(25.92)
|
91.0
(2.59)
|
||
| 180 ± 15 min R elbow |
85.5
(7.77)
|
97.3
(NA)
|
85.9
(NA)
|
109.3
(44.46)
|
71.2
(NA)
|
NA
(NA)
|
102.1
(28.42)
|
94.3
(4.39)
|
90.9
(5.49)
|
||
| 180 ± 15 min L Wrist |
401.8
(201.69)
|
488.6
(40.47)
|
434.0
(183.81)
|
514.7
(275.68)
|
299.7
(126.01)
|
404.1
(126.88)
|
457.9
(157.64)
|
566.6
(374.43)
|
484.7
(164.36)
|
||
| 180 ± 15 min R Wrist |
387.6
(246.92)
|
479.7
(73.26)
|
482.2
(169.64)
|
582.1
(411.89)
|
404.5
(177.65)
|
465.1
(269.97)
|
565.6
(283.40)
|
534.7
(314.36)
|
456.8
(194.99)
|
||
| 180 ± 15 min L MCP1 |
527.8
(355.31)
|
309.9
(57.82)
|
293.9
(93.47)
|
321.2
(169.11)
|
300.3
(136.28)
|
216.6
(17.24)
|
259.7
(56.52)
|
297.4
(107.98)
|
327.7
(58.96)
|
||
| 180 ± 15 min L MCP2 |
259.7
(67.37)
|
378.4
(212.17)
|
404.1
(168.75)
|
316.1
(114.50)
|
252.7
(139.89)
|
225.7
(30.86)
|
300.6
(157.04)
|
364.3
(184.71)
|
237.1
(131.01)
|
||
| 180 ± 15 min L MCP3 |
252.3
(60.46)
|
456.5
(90.38)
|
327.1
(97.70)
|
317.3
(184.41)
|
302.4
(146.85)
|
220.4
(63.17)
|
393.1
(57.80)
|
364.2
(210.61)
|
300.5
(84.15)
|
||
| 180 ± 15 min L MCP4 |
219.8
(44.10)
|
414.3
(76.72)
|
273.5
(71.29)
|
278.8
(139.18)
|
261.5
(128.77)
|
195.4
(39.10)
|
361.9
(60.33)
|
315.2
(195.40)
|
305.5
(97.92)
|
||
| 180 ± 15 min L MCP5 |
179.8
(59.65)
|
413.1
(81.96)
|
203.2
(61.46)
|
264.4
(165.09)
|
251.9
(128.70)
|
184.4
(44.55)
|
276.4
(62.35)
|
298.0
(104.10)
|
228.8
(43.52)
|
||
| 180 ± 15 min R MCP1 |
298.9
(68.07)
|
344.3
(25.68)
|
284.4
(68.47)
|
351.1
(222.79)
|
288.4
(127.85)
|
258.6
(71.85)
|
346.9
(33.49)
|
356.0
(64.44)
|
416.8
(194.14)
|
||
| 180 ± 15 min R MCP2 |
289.9
(37.14)
|
495.1
(256.02)
|
341.6
(126.66)
|
405.0
(343.20)
|
271.4
(146.89)
|
300.3
(147.97)
|
294.3
(40.20)
|
397.0
(170.33)
|
340.5
(169.41)
|
||
| 180 ± 15 min R MCP3 |
320.9
(76.70)
|
428.1
(5.42)
|
286.9
(118.06)
|
404.0
(242.78)
|
300.1
(171.48)
|
298.2
(138.42)
|
330.5
(97.94)
|
385.2
(256.76)
|
367.9
(121.03)
|
||
| 180 ± 15 min R MCP4 |
263.6
(24.44)
|
380.8
(38.83)
|
271.1
(101.92)
|
320.0
(202.62)
|
284.2
(137.20)
|
271.2
(73.89)
|
255.3
(56.27)
|
361.8
(223.67)
|
363.7
(104.49)
|
||
| 180 ± 15 min R MCP5 |
214.5
(37.25)
|
373.2
(122.41)
|
218.4
(67.7)
|
276.1
(168.15)
|
262.1
(140.52)
|
187.3
(34.76)
|
270.6
(58.95)
|
332.5
(162.83)
|
369.2
(77.77)
|
||
| 180 ± 15 min L PIP1 |
179.4
(41.32)
|
270.7
(98.35)
|
177.0
(76.74)
|
220.4
(125.71)
|
224.0
(146.46)
|
156.1
(8.23)
|
206.3
(25.63)
|
275.1
(74.03)
|
254.3
(95.16)
|
||
| 180 ± 15 min L PIP2 |
144.4
(12.55)
|
165.9
(44.85)
|
151.2
(38.91)
|
209.8
(116.11)
|
189.5
(106.68)
|
142.4
(18.60)
|
227.5
(50.02)
|
285.4
(229.72)
|
204.8
(63.14)
|
||
| 180 ± 15 min L PIP3 |
152.4
(45.18)
|
257.6
(126.40)
|
157.8
(72.64)
|
215.3
(120.83)
|
160.7
(81.29)
|
155.2
(54.09)
|
224.2
(5.85)
|
285.6
(241.39)
|
204.4
(84.03)
|
||
| 180 ± 15 min L PIP4 |
133.6
(22.67)
|
185.2
(10.12)
|
150.9
(48.91)
|
195.7
(120.38)
|
167.2
(96.27)
|
157.8
(28.39)
|
249.7
(77.85)
|
246.4
(191.83)
|
198.6
(85.67)
|
||
| 180 ± 15 min L PIP5 |
104.1
(17.04)
|
151.0
(25.51)
|
124.2
(27.15)
|
191.1
(149.39)
|
143.7
(98.53)
|
109.1
(16.35)
|
219.4
(95.36)
|
183.6
(85.21)
|
168.3
(58.47)
|
||
| 180 ± 15 min R PIP1 |
218.6
(53.24)
|
309.0
(60.52)
|
202.1
(67.80)
|
221.3
(133.90)
|
222.0
(117.48)
|
194.1
(32.36)
|
303.2
(62.42)
|
261.8
(138.92)
|
262.7
(83.66)
|
||
| 180 ± 15 min R PIP2 |
193.0
(43.56)
|
204.7
(18.16)
|
174.8
(67.84)
|
256.4
(140.51)
|
187.3
(75.12)
|
164.9
(57.27)
|
211.9
(56.41)
|
200.5
(47.74)
|
225.4
(9.65)
|
||
| 180 ± 15 min R PIP3 |
182.4
(14.8)
|
224.8
(21.69)
|
164.0
(64.36)
|
239.6
(135.40)
|
184.9
(76.62)
|
198.0
(85.74)
|
255.0
(65.78)
|
263.1
(120.11)
|
229.3
(44.24)
|
||
| 180 ± 15 min R PIP4 |
164.6
(30.74)
|
376.6
(103.08)
|
175.3
(78.67)
|
213.4
(147.22)
|
170.3
(97.90)
|
182.8
(47.32)
|
243.5
(36.60)
|
292.8
(174.85)
|
196.2
(108.71)
|
||
| 180 ± 15 min R PIP5 |
125.7
(8.97)
|
200.3
(73.56)
|
119.7
(30.65)
|
181.4
(90.31)
|
148.5
(64.16)
|
117.3
(44.55)
|
147.5
(47.18)
|
233.4
(102.14)
|
197.7
(50.77)
|
||
| 180 ± 15 min L Knee |
80.5
(26.70)
|
113.8
(39.80)
|
104.5
(27.67)
|
126.1
(43.18)
|
98.6
(25.98)
|
87.5
(37.21)
|
101.2
(32.64)
|
193.7
(177.10)
|
146.8
(22.71)
|
||
| 180 ± 15 min R Knee |
92.5
(39.11)
|
126.5
(47.90)
|
124.0
(40.28)
|
122.1
(40.79)
|
105.3
(23.75)
|
76.5
(11.68)
|
107.5
(37.05)
|
191.4
(180.37)
|
151.8
(25.49)
|
| Title | Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA |
|---|---|
| Description | Per subject localization rate of Tc 99m tilmanocept in areas other than RA is defined as the number of subjects with at least one localized DAS28 joint per number of subjects in the analysis population. |
| Time Frame | Imaging taken 60 ± 15 min and 180 ± 15 min post-injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only Groups 1-9. Groups 10 & 11 were not included in the population these endpoints were evaluated for. |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Measure Participants | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 0 | 0 |
| Number of subjects localized at 60 ± 15 min |
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
||
| Number of subjects localized at 180 ± 15 min |
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
3
100%
|
| Title | Maximum Observed Concentration (Cmax) |
|---|---|
| Description | Maximum observed concentration (Cmax) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine. |
| Time Frame | 15 minutes prior to administration. Immediately after administration. 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only in Groups 10 and 11 |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
| Mean (90% Confidence Interval) [nCi/mL] |
1244.2
|
2043.8
|
| Title | Time to Cmax (Tmax) |
|---|---|
| Description | Time to Cmax (tmax) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine. |
| Time Frame | Radioactivity was quantitated at each time point -15 mins prior to administration• Immediately after administration •15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post admi |
Outcome Measure Data
| Analysis Population Description |
|---|
| Groups 10 and 11 |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
| Mean (Standard Deviation) [minutes] |
27.3
(7.36)
|
255
(6.58)
|
| Title | Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measureable Concentration (AUC0-t) |
|---|---|
| Description | Area under the concentration-time curve (AUC) from Hour 0 to the last measureable concentration (18 to 20 hours) (AUC0-t) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine. |
| Time Frame | Hour 0 to hour 18-20, with time points immediately post injection, 0.25 hr, 1 hr, 3 hr and 18-20 hr after injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Groups 10 and 11 |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
| Whole blood AUC |
235258.0
|
268110.7
|
|||||||||
| Urine AUC |
1468788.9
|
1384642.0
|
| Title | AUC Extrapolated to Infinity |
|---|---|
| Description | AUC extrapolated to infinity will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine. |
| Time Frame | 15 mins prior to administration • Immediately after administration • 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Groups 10 and 11 only. |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
| Mean (90% Confidence Interval) [min*nCi/mL] |
370580.1
|
396026.4
|
| Title | Apparent Terminal Elimination Rate Constant (Z) |
|---|---|
| Description | Apparent terminal elimination rate constant (Z) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine. |
| Time Frame | 15 mins prior to administration • Immediately after administration • 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Groups 10 and 11 only. |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
| Mean (90% Confidence Interval) [1/minute] |
0.00094
|
0.00100
|
| Title | Apparent Terminal Elimination Half-life (t1/2) |
|---|---|
| Description | Apparent terminal elimination half-life (t1/2) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine. |
| Time Frame | 15 mins prior to administration • Immediately after administration • 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Groups 10 and 11. |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
| Mean (90% Confidence Interval) [minutes] |
759.0
|
719.1
|
| Title | Radiation Dosimetry of Tc 99m Tilmanocept |
|---|---|
| Description | Mean total radiation dose per organ (mSv/MBq) in HC females, HC males, females with active RA, and males with active RA. Results were obtained at the subject level from Hybrid Dosimetry™ Version 2.8.3 and OLINDA/EXM® Version 2.1RC93 in accordance with NAV3-21 Protocol Amendment 6. The Hybrid Dosimetry™ function provides an efficient way to generate kinetic data for selected organs via regions of interest (ROI) drawing. From this data, residence times are calculated and transferred to OLINDA/EXM®, which generates absorbed dose tables using the MIRD methodology. |
| Time Frame | Planar images were taken 15 ± 5 minutes, 60 ± 5 minutes, 180 ± 5 minutes, 18 to 20 hours after Tc 99m tilmanocept administration and processed in accordance with the NAV3-21 protocol endpoints using established dosimetry software. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Groups 10 and 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. |
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (HC Females) | Group 10 (HC Males) | Group 11 (RA Females) | Group 11 (RA Males) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 | 3 |
| Mean (Standard Deviation) [mSv/MBq] |
4.69
(4.54)
|
2.69
(1.13)
|
5.06
(4.93)
|
3.02
(2.97)
|
Adverse Events
| Time Frame | 53 days | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||||||
| Arm/Group Title | Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) | |||||||||||
| Arm/Group Description | Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. SPECT Imaging (60 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. SPECT Imaging (180 Minutes post-injection): Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. Planar Image with both Hands in Field of View: Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. | Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection). | |||||||||||
All Cause Mortality |
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| Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||
Serious Adverse Events |
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| Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||||||
Other (Not Including Serious) Adverse Events |
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| Group 1 (RA) | Group 2 (RA) | Group 3 (RA) | Group 4 (RA) | Group 5 (RA) | Group 6 (RA) | Group 7 (RA) | Group 8 (RA) | Group 9 (RA) | Group 10 (Healthy Controls) | Group 11 (RA) | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 2/6 (33.3%) | 1/6 (16.7%) | |||||||||||
| Endocrine disorders | ||||||||||||||||||||||
| Hypoglycemia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | ||
| Gastrointestinal disorders | ||||||||||||||||||||||
| Nausea | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/6 (16.7%) | 1 | 0/6 (0%) | 1 | |||||||||
| Vomiting | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/6 (16.7%) | 1 | 0/6 (0%) | 1 | |||||||||
| General disorders | ||||||||||||||||||||||
| Fatigue | 1/3 (33.3%) | 1 | 0/3 (0%) | 1 | 0/3 (0%) | 1 | 0/3 (0%) | 1 | 0/3 (0%) | 1 | 0/3 (0%) | 1 | 0/3 (0%) | 1 | 0/3 (0%) | 1 | 0/3 (0%) | 1 | 0/6 (0%) | 1 | 0/6 (0%) | 1 |
| Infections and infestations | ||||||||||||||||||||||
| Urinary Tract Infection | 2/3 (66.7%) | 2 | 0/3 (0%) | 2 | 0/3 (0%) | 2 | 0/3 (0%) | 2 | 0/3 (0%) | 2 | 0/3 (0%) | 2 | 0/3 (0%) | 2 | 0/3 (0%) | 2 | 0/3 (0%) | 2 | 0/6 (0%) | 2 | 0/6 (0%) | 2 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||
| Blister | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1 | 0/3 (0%) | 1 | 0/6 (0%) | 1 | 0/6 (0%) | 1 | |||||||
| Dermatitis Contact | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1 | 0/3 (0%) | 1 | 0/3 (0%) | 1 | 0/3 (0%) | 1 | 0/6 (0%) | 1 | 0/6 (0%) | 1 | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and make modifications to the publication.
Results Point of Contact
| Name/Title | Bonnie Abbruzzzese |
|---|---|
| Organization | Navidea Biopharmaceuticals |
| Phone | 6147937500 |
| babbruzzese@navidea.com |
Responsible Party:
Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT02865434
Other Study ID Numbers:
- NAV3-21
First Posted:
Aug 12, 2016
Last Update Posted:
Aug 12, 2021
Last Verified:
Aug 1, 2021