Ignite Creation Date:
2024-05-06 @ 9:37 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03029988
Status:
TERMINATED
Last Update Posted:
2020-09-10
First Post:
2017-01-20
Brief Title:
An Evaluation of Tilmanocept by IV Injection Using SPECTCT vs PET Imaging in Subjects With Liver Metastases
Sponsor:
Navidea Biopharmaceuticals
Organization:
Navidea Biopharmaceuticals
Study Overview
Official Title:
An Exploratory Evaluation of Technetium Tc 99m Tilmanocept by Intravenous IV Injection in Subjects With Liver Metastases From Colorectal Carcinoma Patients Using SPECTCT Imaging Compared to Fluorodeoxyglucose FDG PETCT Imaging
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of effect in Cohort 1
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Estimation of the concordance of Tc 99m localization in liver metastases from colorectal carcinoma using SPECTCT imaging and abdominal FDG PETCT 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 SPECTCT imaging of the subjects abdominal cavity will be reviewed to establish concordance with FDG PET imaging
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 SPECTCT imaging of the subjects abdominal cavity will be reviewed to establish concordance with FDG PET imaging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R44CA162783-01 | NIH | None | httpsreporternihgovquickSearch1R44CA162783-01 |