Low Dose ICG for Biliary Tract and Tumor Imaging

Hepatocellular Carcinoma Clinical Trial

— ICG  

Official title:

Low Dose ICG for Near-infrared Fluorescence Imaging of Biliary Tract and Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942665
• Other study ID #: IRB202100388
• Secondary ID: OCR40380PRO00043
• Status: Completed
• Phase: Phase 2
• Start date: September 15, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 1, 2023
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cholecystitis
• Hepatocellular Carcinoma
• Liver Metastases

Intervention

Drug:
• Indocyanine green
Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).

Device:
• PINPOINT Endoscopic Fluorescence
The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging.

Locations

Country	Name	City	State
United States	University of Florida Health Shands	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Society of University Surgeons

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio	Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver	intraoperative, average of 2 hours
Secondary	Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light	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).	intraoperative, average of 2 hours
Secondary	Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio	Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the background fat	intraoperative, average of 2 hours
Secondary	Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)	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).	intraoperative, average of 2 hours