Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-01-01 @ 11:34 AM
Study NCT ID:
NCT03946761
Status:
WITHDRAWN
Last Update Posted:
2022-01-24
First Post:
2019-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorescence Imaging in Hepatobiliary Surgery
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Evaluation of Fluorescence Imaging in Hepatobiliary Surgery
Status:
WITHDRAWN
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
One of the main investigators is leaving the University.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A current gap in the use indocyanine green fluorescence to isolate the biliary system is the dosing amount necessary to fluoresce the biliary system without "over" fluorescing the liver and gallbladder. Over fluorescing surrounding structures such as the liver and gallbladder saturates the image and makes it impossible to identify biliary leaks or differentiate branches of the common bile duct using fluorescent imaging devices. The over dosing does not affect the standard of care procedure, but eliminates the added benefit of the fluorescent imaging technology. The use of "microdoses" (approximately 0.1 mg) of indocyanine green has been trialed and shown promise in some patients. This study aims to do an in depth study utilizing the Cancer goggle systems fluorescent imaging system to determine the correct dose needed to isolate the biliary system without over fluorescing surrounding structures. This dosing study could additionally serve as a pilot study for follow on research using indocyanine green and fluorescent imaging in hepatobiliary surgery.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: