A Phase 1 interventional study of Tilmanocept (Technetium Tc 99m tilmanocept Injection) and SPECT/CT Imaging in Liver Metastases and Colorectal Carcinoma, sponsored by Navidea Biopharmaceuticals. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-10.
Sponsored by Navidea Biopharmaceuticals · Phase 1, Interventional, and Diagnostic
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.
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.
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's enrollment of 3 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Navidea Biopharmaceuticals is the lead sponsor of 19 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
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Exclusion Criteria:
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) · Procedure: SPECT/CT Imaging
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) · Procedure: SPECT/CT Imaging
Drug: Technetium Tc 99m tilmanocept
Also known as: Lymphoseek
4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.
Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging.
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
| Milestone | Cohort 1 |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
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.
| Lesions | Cohort 1 - FDG PET CT | Cohort 1 - Tilmanocept SPECT/CT |
|---|---|---|
| Liver | 7 | 0 |
| Colon | 1 | 0 |
Collected over 35 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Event | Cohort 1 |
|---|---|
| LeukocytosisBlood and lymphatic system disorders | 1/3 |
| UrticariaSkin and subcutaneous tissue disorders | 1/3 |
No subjects enrolled in Cohort 2
| Age, Categorical(Participants) | Cohort 1 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Age, Continuous(years) | Cohort 1 |
|---|---|
| Mean | 44.3 ± 16.80 |
| Sex: Female, Male(Participants) | Cohort 1 |
|---|---|
| Female | 3 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 1 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Cohort 1 |
|---|---|
| United States | 3 |
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Navidea Biopharmaceuticals