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Low Dose ICG for Biliary Tract and Tumor Imaging (ICG)

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ClinicalTrials.gov Identifier: NCT04942665
Recruitment Status : Recruiting
First Posted : June 28, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cholecystitis Hepatocellular Carcinoma Liver Metastases Drug: Indocyanine green Device: PINPOINT Endoscopic Fluorescence Phase 2

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. 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Diagnostic
Official Title: Low Dose ICG for Near-infrared Fluorescence Imaging of Biliary Tract and Tumors
Actual Study Start Date : September 15, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Dose
Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.
 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.
Placebo Comparator: Standard Dose
Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Imaging intraoperative visualization of the extrahepatic biliary tree [ Time Frame: intraoperative - 1 day ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04942665


Locations
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United States, Florida
University of Florida Health Shands Recruiting
Gainesville, Florida, United States, 32610
Contact: Ali Zarrinpar, MD PhD    352-265-0606    ali.zarrinpar@surgery.ufl.edu   
Contact: Tyler J Loftus, MD    (352) 273-9440    tyler.loftus@surgery.ufl.edu   
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Ali Zarrinpar, MD, PhD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04942665    
Other Study ID Numbers: IRB202100388
OCR40380 ( Other Identifier: UF OnCore )
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are not sharing individual participant data with other researchers

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Florida:
Biliary Tract
Indocyanine Green (ICG)
Tumors
Near-infrared Fluorescence
Additional relevant MeSH terms:
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Cholecystitis
Digestive System Diseases
Gallbladder Diseases
Biliary Tract Diseases