Low Dose ICG for Biliary Tract and Tumor Imaging

Phase 2

Completed

• Conditions: Cholecystitis; Hepatocellular Carcinoma; Liver Metastases
• Interventions: Drug: Indocyanine green; Device: PINPOINT Endoscopic Fluorescence

• Registration Number: NCT04942665
• Lead Sponsor: University of Florida

Brief Summary

Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green (ICG) allows for the intraoperative identification of liver anatomy. The investigators have new data that a much lower dose improves this visualization. Confirmation of this hypothesis would mean that ICG can be administered on the same day of surgery in order to augment real-time intraoperative visualization, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.

Detailed Description

The investigators have a series of surgical cases in which the investigators have been able to achieve excellent intraoperative biliary visualization with a greatly decreased (50-200 fold lower) dose of ICG than the previously published dose. Furthermore, this decreased dose was visible in about 15-20 minutes from the time of injection with low liver background fluorescence, a significant improvement that would make its utilization in the operating room more practical. The investigators hypothesize that a lower dose will: 1) allow adequate visualization of the extrahepatic biliary tree, including the cystic, common hepatic, and common bile ducts. Confirmation of hypotheses would mean that a lower dose of ICG can be administered on the same day of surgery in order to augment real-time intraoperative localization of the extrahepatic biliary tree, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.

The investigators intend to test our hypothesis with the following specific aims:

Aim 1: To compare the efficacy and utility of a low dose ICG (0.05 mg) protocol with a previously published dose (2.5 mg) in imaging the extrahepatic biliary tract.

Study Timeline

• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-06-25
• Study First Posted: 2021-06-28
• Study Start: 2021-09-15
• Primary Completion: 2022-09-15
• Study Completion: 2023-04-01
• Results First Submitted: 2023-06-12
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-09
• Last Update Submitted: 2023-08-09
• Results First Posted: 2023-08-30
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients undergoing standard of care laparoscopic hepatic or biliary operations or Patients undergoing standard of care laparoscopic resection for hepatic tumors: hepatocellular carcinoma or metastatic tumor

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Exclusion Criteria

• Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes and Pregnant and/or lactating patients.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose	PINPOINT Endoscopic Fluorescence	Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.
Standard Dose	PINPOINT Endoscopic Fluorescence	Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV.
Low Dose	Indocyanine green	Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.
Standard Dose	Indocyanine green	Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV.

Primary Outcome Measures

Name	Time	Method
Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio	intraoperative, average of 2 hours	Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver

Secondary Outcome Measures

Name	Time	Method
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)	intraoperative, average of 2 hours	A qualitative assessment will be made based on the quality of the intraoperative visualization of the extrahepatic biliary tree on a scale of 1 to 5 (1 = no improvement/identification not confirmed; 2 = marginally improved; 3 = sufficiently improved; 4 = well improved; 5 = greatly improved/exceeds expectations).
Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio	intraoperative, average of 2 hours	Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the background fat
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light	intraoperative, average of 2 hours	A qualitative assessment will be made based on the quality of the intraoperative visualization of the extrahepatic biliary tree on a scale of 1 to 5 (1 = no improvement/identification not confirmed; 2 = marginally improved; 3 = sufficiently improved; 4 = well improved; 5 = greatly improved/exceeds expectations).

Trial Locations

Locations (1)

University of Florida Health Shands; 🇺🇸 Gainesville, Florida, United States