An Evaluation of Tilmanocept by IV Injection Using SPECT/CT vs PET Imaging in Subjects With Liver Metastases.
Study Details
Study Description
Brief Summary
Estimation of the concordance of Tc 99m localization in liver metastases from colorectal carcinoma using SPECT/CT imaging and abdominal FDG (PET)/CT imaging per subject.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This is a prospective, open-label, single-center, comparator study of IV injected Tc 99m Tilmanocept in the localization and detection of liver metastases in subjects with confirmed colorectal carcinoma (CRC). The study will be divided into two cohorts.
If it was determined that additional enrollment would not provide meaningful data, for example no metastatic liver lesions were visualized by Tc 99m tilmanocept for any of the subjects in the cohort, enrollment into Cohort 2 would begin and 3 subjects would be enrolled followed by a review of the imaging and safety data.
This study is designed to evaluate the safety and tolerability of Tc 99m tilmanocept administered intravenously. SPECT/CT imaging of the subject's abdominal cavity will be reviewed to establish concordance with FDG PET imaging.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 millicuries (mCi) Tc99m through a single IV injection. |
Drug: Tilmanocept (Technetium Tc 99m tilmanocept Injection)
Drug: Technetium Tc 99m tilmanocept
Other Names:
Procedure: SPECT/CT Imaging
4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.
|
| Experimental: Cohort 2 Subjects will receive 200 µg tilmanocept radiolabeled with 2.0 mCi Tc99m through a single IV injection. If it was determined that additional enrollment would not provide meaningful data, for example no metastatic liver lesions were visualized by Tc 99m tilmanocept for any of the subjects in the cohort, enrollment into Cohort 2 would begin and 3 subjects would be enrolled followed by a review of the imaging and safety data. |
Drug: Tilmanocept (Technetium Tc 99m tilmanocept Injection)
Drug: Technetium Tc 99m tilmanocept
Other Names:
Procedure: SPECT/CT Imaging
4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.
|
Outcome Measures
Primary Outcome Measures
- Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging. [Within 7 days after Tc 99m tilmanocept administration]
The primary objectives of this study were to estimate the concordance of Tc 99m tilmanocept localization in liver metastases from colorectal carcinoma (CRC) using single photon emission computed tomography / computed tomography (SPECT/CT) imaging and abdominal fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) imaging per subject and to evaluate the safety including monitoring the incidence of adverse events and changes over time in laboratory tests, vital signs, and physical examination findings.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The subject has provided written informed consent with Health Information Portability and Accountability Act (HIPAA) authorization before the initiation of any study-related procedures.
-
Subjects must be ≥18 years old;
-
The subject must have a diagnosis of adenocarcinoma of the colon and/or rectum with FDG PET/CT confirmed metastases to the liver;
-
The subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
-
The subject must be at least 4 weeks past any major intraabdominal surgery, including surgery to the liver;
-
Subjects with prior malignancies other than colon and/or rectum cancer are allowed, provided they have been treated with curative intent, and have no evidence of recurrence of that malignancy;
-
Each subject must have no more than 10 qualifying liver lesions that have been clinically confirmed metastatic adenocarcinoma of the colon by FDG PET/CT imaging.
-
If of childbearing potential, the subject has a negative urine pregnancy test within 48 hours before administration of Tc 99m Tilmanocept, has been surgically sterilized, or has been postmenopausal for at least 1 year
Exclusion Criteria:
-
The subject is pregnant or lactating.
-
The subject has undergone any liver surgery, exclusive of a biopsy.
-
The subject has known sensitivity to dextran.
-
The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy within the 10 days prior to Tc 99m Tilmanocept administration
-
Before the administration of Tc 99m Tilmanocept, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
-
Has received an investigational product within the 30 days prior to Tc 99m Tilmanocept administration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Birmingham | Birmingham | Alabama | United States | 35249 |
Sponsors and Collaborators
- Navidea Biopharmaceuticals
- National Institutes of Health (NIH)
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Frederick O Cope, PhD, Navidea Biopharmaceuticals
Study Documents (Full-Text)
More Information
Publications
None provided.- NAV3-25
- 1R44CA162783-01
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cohort 1 |
|---|---|
| Arm/Group Description | Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 millicuries (mCi) Tc99m through a single IV injection. Tilmanocept (Technetium Tc 99m tilmanocept Injection): Drug: Technetium Tc 99m tilmanocept SPECT/CT Imaging: 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region. |
| Period Title: Overall Study | |
| STARTED | 3 |
| COMPLETED | 3 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Cohort 1 |
|---|---|
| Arm/Group Description | Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 mCi Tc99m through a single IV injection. Tilmanocept (Technetium Tc 99m tilmanocept Injection): Drug: Technetium Tc 99m tilmanocept SPECT/CT Imaging: 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region. |
| Overall Participants | 3 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
3
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
44.3
(16.80)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
3
100%
|
| Male |
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
3
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
1
33.3%
|
| White |
1
33.3%
|
| More than one race |
1
33.3%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
3
100%
|
Outcome Measures
| Title | Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging. |
|---|---|
| Description | The primary objectives of this study were to estimate the concordance of Tc 99m tilmanocept localization in liver metastases from colorectal carcinoma (CRC) using single photon emission computed tomography / computed tomography (SPECT/CT) imaging and abdominal fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) imaging per subject and to evaluate the safety including monitoring the incidence of adverse events and changes over time in laboratory tests, vital signs, and physical examination findings. |
| Time Frame | Within 7 days after Tc 99m tilmanocept administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cohort 1 - FDG PET CT | Cohort 1 - Tilmanocept SPECT/CT |
|---|---|---|
| Arm/Group Description | At screening, an FDG PET/CT scan was done in accordance with standard procedures | Subjects received 50 µg tilmanocept radiolabeled with 2.0 mCi Tc 99m through a single IV injection. SPECT/CT imaging of the abdominal region occurred 4-6 hours post-injection. Note: The liver lesion visualized by FDG PET/CT was excised prior to SPECT/CT imaging. |
| Measure Participants | 3 | 3 |
| Liver |
7
|
0
|
| Colon |
1
|
0
|
Adverse Events
| Time Frame | 35 days | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Cohort 1 | |
| Arm/Group Description | Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 mCi Tc99m through a single IV injection. Tilmanocept (Technetium Tc 99m tilmanocept Injection): Drug: Technetium Tc 99m tilmanocept SPECT/CT Imaging: 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region. | |
All Cause Mortality |
||
| Cohort 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | |
Serious Adverse Events |
||
| Cohort 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Cohort 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/3 (66.7%) | |
| Blood and lymphatic system disorders | ||
| Leukocytosis | 1/3 (33.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Urticaria | 1/3 (33.3%) | 1 |
Limitations/Caveats
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 Abbruzzese Senior Director |
|---|---|
| Organization | Navidea Biopharmaceuticals |
| Phone | 614.793.7500 ext 147 |
| babbruzzese@navidea.com |
- NAV3-25
- 1R44CA162783-01