Low Dose ICG for Biliary Tract and Tumor Imaging

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Brief Title

Low Dose ICG for Biliary Tract and Tumor Imaging

Official Title

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

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 and 2) result in adequate retention of ICG in both primary and metastatic
      tumors of the liver, facilitating tumor visualization. Confirmation of either of these
      hypotheses would mean that ICG can be administered on the same day of surgery in order to
      augment real-time intraoperative localization of the extrahepatic biliary tree and hepatic
      tumors, 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.

      Aim 2: To compare the efficacy and utility of a same day, low dose ICG (0.05 mg) protocol
      with a previously published dose (2.5 mg) of ICG administered 1-7 days prior to surgery in
      imaging hepatocellular carcinoma and metastatic liver masses.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Imaging intraoperative visualization of the extrahepatic biliary tree

Secondary Outcome

 Imaging hepatocellular carcinoma and metastatic liver masses

Condition

Cholecystitis

Intervention

Indocyanine green

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

105

Start Date

September 2021

Completion Date

June 30, 2024

Primary Completion Date

June 30, 2023

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Ali Zarrinpar, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04942665

Organization ID

IRB202100388


Responsible Party

Sponsor

Study Sponsor

University of Florida


Study Sponsor

Ali Zarrinpar, MD, PhD, Principal Investigator, University of Florida


Verification Date

July 2021