Trials / Terminated
TerminatedNCT03029988
An Evaluation of Tilmanocept by IV Injection Using SPECT/CT vs PET Imaging in Subjects With Liver Metastases.
An Exploratory Evaluation of Technetium Tc 99m Tilmanocept by Intravenous (IV) Injection in Subjects With Liver Metastases From Colorectal Carcinoma Patients Using SPECT/CT Imaging Compared to Fluorodeoxyglucose (FDG) PET/CT Imaging.
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Navidea Biopharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tilmanocept (Technetium Tc 99m tilmanocept Injection) | Drug: Technetium Tc 99m tilmanocept |
| PROCEDURE | SPECT/CT Imaging | 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region. |
Timeline
- Start date
- 2017-07-26
- Primary completion
- 2018-09-24
- Completion
- 2018-09-24
- First posted
- 2017-01-24
- Last updated
- 2020-09-10
- Results posted
- 2019-11-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03029988. Inclusion in this directory is not an endorsement.