Low Dose ICG for Biliary Tract and Tumor Imaging

Completed · Phase 2

Conditions studied: Cholecystitis, Hepatocellular Carcinoma, Liver Metastases

In brief

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.

Key facts

Study ID

NCT04942665

Run by

University of Florida

People needed

60

Starts

2021-09-15

Expected to finish

2023-04-01

Last updated by the study team

2023-08-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• University of Florida Health Shands — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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