Low Dose ICG for Biliary Tract and Tumor Imaging

University of Florida

Status and phase: Completed; Phase 2

Conditions: Cholecystitis; Liver Metastases; Hepatocellular Carcinoma

Treatments: Drug: Indocyanine green; Device: PINPOINT Endoscopic Fluorescence

Study type: Interventional

Funder types: Other

Identifiers

NCT04942665

PRO00043219 (Other Identifier)

OCR40380 (Other Identifier)

IRB202100388

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Low Dose

Experimental group

Description:

Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.

Treatment:

Device: PINPOINT Endoscopic Fluorescence

Drug: Indocyanine green

Standard Dose

Placebo Comparator group

Description:

Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV.

Treatment:

Device: PINPOINT Endoscopic Fluorescence

Drug: Indocyanine green