Trial Outcomes & Findings for An Evaluation of Tilmanocept by IV Injection Using SPECT/CT vs PET Imaging in Subjects With Liver Metastases. (NCT NCT03029988)
NCT ID: NCT03029988
Last Updated: 2020-09-10
Results Overview
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.
TERMINATED
PHASE1
3 participants
Within 7 days after Tc 99m tilmanocept administration
2020-09-10
Participant Flow
Participant milestones
| Measure |
Cohort 1
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.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Evaluation of Tilmanocept by IV Injection Using SPECT/CT vs PET Imaging in Subjects With Liver Metastases.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 16.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after Tc 99m tilmanocept administrationThe 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.
Outcome measures
| Measure |
Cohort 1 - FDG PET CT
n=3 Participants
At screening, an FDG PET/CT scan was done in accordance with standard procedures
|
Cohort 1 - Tilmanocept SPECT/CT
n=3 Participants
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.
|
|---|---|---|
|
Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging.
Liver
|
7 Lesions
|
0 Lesions
|
|
Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging.
Colon
|
1 Lesions
|
0 Lesions
|
Adverse Events
Cohort 1
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
33.3%
1/3 • Number of events 1 • 35 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
33.3%
1/3 • Number of events 1 • 35 days
|
Additional Information
Bonnie Abbruzzese Senior Director
Navidea Biopharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER