Low Dose ICG for Biliary Tract and Tumor Imaging

NCT04942665 | Completed Phase 2 Results FDA Drug FDA Device

• 3 other identifiers: IRB202100388OCR40380PRO00043219
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis; Hepatocellular Carcinoma; Liver Metastases

Keywords

Biliary Tract; Indocyanine Green (ICG); Tumors; Near-infrared Fluorescence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light

  intraoperative, average of 2 hours

• Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio

  intraoperative, average of 2 hours

• 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

Study Arms (2)

Low Dose

EXPERIMENTAL

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

Drug: Indocyanine green; Device: PINPOINT Endoscopic Fluorescence

Standard Dose

PLACEBO COMPARATOR

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

Drug: Indocyanine green; Device: PINPOINT Endoscopic Fluorescence

Interventions

Indocyanine green DRUG

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).

Also known as: ICG

Low Dose; Standard Dose

PINPOINT Endoscopic Fluorescence DEVICE

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.

Also known as: NIRF

Low Dose; Standard Dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Florida: lead
• Society of University Surgeons: collaborator

Study Sites (1)

University of Florida Health Shands

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• Ladd AD, Zarate Rodriguez J, Lewis D, Warren C, Duarte S, Loftus TJ, Nassour I, Soma D, Hughes SJ, Hammill CW, Zarrinpar A. Low vs Standard-Dose Indocyanine Green in the Identification of Biliary Anatomy Using Near-Infrared Fluorescence Imaging: A Multicenter Randomized Controlled Trial. J Am Coll Surg. 2023 Apr 1;236(4):711-717. doi: 10.1097/XCS.0000000000000553. Epub 2023 Jan 10.

  PMID: 36728303 DERIVED

MeSH Terms

Conditions

Cholecystitis; Carcinoma, Hepatocellular; Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Liver Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Ali Zarrinpar
• Organization: University of Florida

ali.zarrinpar@surgery.ufl.edu

(352) 265-0606

Study Officials

• Ali Zarrinpar, MD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To mask the investigator randomization will be done with envelopes for this study and the dose given to the patient prior to surgery with the investigator not being aware of the amount given.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adult patients scheduled to undergo a laparoscopic hepatic or biliary operation will be randomized to two groups 1) low dose (0.05 mg) or 2) standard dose (2.5 mg) of ICG preoperatively on the day of surgery. Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes will be excluded.

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 28, 2021
• Study Start: September 15, 2021
• Primary Completion: September 15, 2022
• Study Completion: April 1, 2023
• Last Updated: August 30, 2023
• Results First Posted: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)