Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging
Study Details
Study Description
Brief Summary
This study is an evaluation of the precision and sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Planar Imaging
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
This is a Manocept Platform prospective, open-label, multicenter, single and repeat-dose study designed to evaluate the reliability and sensitivity of TUV assessments in HCs and subjects with active RA.
This study is stratified into 3 arms. The first 2 arms, comprised of [1] disease-free HCs and [2] clinically diagnosed RA subjects on stable treatment. The third arm is designed to assess the efficacy of TUV global in clinically diagnosed subjects with active RA..
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Subjects Free of Inflammatory Disease The first arms is comprised of [1] disease-free HCs and [2] clinically diagnosed RA subjects on stable treatment, respectively, are designed to apprise the image re-image and/or test re-test (i.e., repeat dose) consistency of joint-specific and global TUVs across a variety of image acquisition intervals |
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:
|
| Experimental: RA Subjects on Stable Therapy The second arm is comprised of [1] disease-free HCs and [2] clinically diagnosed RA subjects on stable treatment, respectively, are designed to apprise the image re-image and/or test re-test (i.e., repeat dose) consistency of joint-specific and global TUVs across a variety of image acquisition intervals |
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:
|
| Experimental: Candidates for Initiation of, or Change to, The third arm is designed to assess the efficacy of TUV global in clinically diagnosed subjects with active RA who are candidates for initiation of, or change to, a new anti-TNFα bDMARD therapy. |
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:
|
Outcome Measures
Primary Outcome Measures
- Arms 1 & 2 (Assess camera-specific precision of TUVjoint and TUVglobal) [Through study completion, up 42 days.]
The camera-specific precision of TUVjoint and TUVglobal in subjects with active RA and Healthy Controls (HCs), which is described as the Root Mean Square Difference (RMSD) between the 15-minute planar images. The stability of the mean/variance relationship, which is assessed by comparing the Coefficient of Variation (CV) of TUVjoint and TUVglobal in subjects with active RA and HCs.
- Arm 2 (stability of the mean/variance relationship) [Up to 42 days]
The stability of the mean/variance relationship, which is assessed by comparing the Coefficient of Variation (CV) of TUVjoint and TUVglobal in subjects with active RA and HCs.
- Arm 3 (correlation of TUVglobal[5w] and response to therapy) [Up to 213 days]
The correlation of ΔTUVglobal[5w] and response to new anti-TNFα bDMARD therapy defined by the change from baseline (CFB) of CDAI to 12 ± 1 weeks(ΔCDAI12w ).• The correlation of ΔTUVglobal[5w] and response to new anti-TNFα bDMARD therapy from baseline to 12 ± 1 weeks defined by ACR Response Criteria (ACR12w)
Secondary Outcome Measures
- Arm 1 (Assess temporal stability) [Through study completion, up to 38 days.]
The temporal stability of the 150 mcg tilmanocept mass dose/10 mCi radiolabeling dose, which is defined as the TDI7.5% between the 1-hour and 3-hour planar images. TUV_global
- Arm 2 (detecting localization within synovial spaces) [Through study completion, up to 42 days.]
The qualitative evaluations of SPECT/CT in detecting localization within synovial spaces of the bilateral hands and wrists.
- Arm 3 (correlation of TUVglobal[0week] and response to therapy) [Up to 213 days]
The correlation of the TUVglobal[0week] and response to new anti-TNFα bDMARD therapy defined by the change from baseline (CFB) of CDAI to 12 ± 1 weeks and 24 ± 1 weeks (ΔCDAI12w and ΔCDAI24w, respectively) and by ACR Response Criteria (ACR12w and ACR24w, respectively).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The subject is at least 18 years of age and was ≥ 18 years of age at the time of RA diagnosis.
-
The subject has moderate to severe RA as determined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria (score of ≥ 6/10).
-
The subject has a 28-joint disease activity score (DAS28) of ≥ 3.2 (includes the Erythrocyte Sedimentation Rate [ESR] test and Visual Analog Scale [VAS]).
-
Subjects receiving traditional DMARDs must have been on therapy for ≥ 90 days and at a stable dose for ≥ 30 days prior to the first imaging visit (Day 0).
-
If the subject is receiving bDMARD or janus kinase (JAK) inhibitor therapy, they have been at a stable dose > 180 days prior to the first imaging visit (Day 0).
-
If the subject is receiving NSAIDs or oral corticosteroids, the dose has been stable for > 28 days prior to first imaging visit (Day 0). The corticosteroid dose must be ≤ 10 mg/day of prednisone or an equivalent steroid dose.
-
ARM 3 (only): The subject is receiving anti-rheumatic treatment and is a candidate for initiation of, or change to, a new anti-TNFα bDMARD treatment.
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.
-
The subject has renal insufficiency as demonstrated by a glomerular filtration rate of < 60 mL/min.
-
The subject has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase [SGPT]) or AST (aspartate aminotransferase [SGOT]) greater than 3 times the upper limit of normal.
-
The subject has any severe, acute, or chronic medical conditions and/or psychiatric conditions and/or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration that would deem the subject inappropriate for study 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 (Day 0).
-
The subject has received intra-articular corticosteroid injections ≤ 8 weeks prior to the first imaging visit (Day 0).
-
The subject has received any radiopharmaceutical within 7 days or 10 half-lives prior to the administration of Tc 99m tilmanocept at the first imaging visit (Day 0).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Imaging Endpoints | Scottsdale | Arizona | United States | 85258 |
| 2 | Axis Clinical Trials | Los Angeles | California | United States | 90036 |
| 3 | University of California San Francisco | San Francisco | California | United States | 94110 |
| 4 | Innovation Medical Research Center | Palmetto Bay | Florida | United States | 33157 |
| 5 | Physician Research Collaboration | Lincoln | Nebraska | United States | 68516 |
| 6 | University Hospitals | Cleveland | Ohio | United States | 44106 |
| 7 | Kettering Medical Center | Kettering | Ohio | United States | 45429 |
| 8 | Central States Research | Tulsa | Oklahoma | United States | 74136 |
| 9 | Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
| 10 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- Navidea Biopharmaceuticals
Investigators
- Study Director: Michael Blue, MD, Navidea Biopharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NAV3-31