Low Dose ICG for Biliary Tract and Tumor Imaging (ICG)
August 9, 2023 updated by: University of Florida
Low Dose ICG for Near-infrared Fluorescence Imaging of Biliary Tract and Tumors
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida Health Shands
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low Dose
Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.
|
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).
Other Names:
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.
Other Names:
|
|
Placebo Comparator: Standard Dose
Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV.
|
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).
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio
Time Frame: intraoperative, average of 2 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light
Time Frame: intraoperative, average of 2 hours
|
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).
|
intraoperative, average of 2 hours
|
|
Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio
Time Frame: intraoperative, average of 2 hours
|
Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the background fat
|
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)
Time Frame: intraoperative, average of 2 hours
|
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).
|
intraoperative, average of 2 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative assessment of overall intraoperative visualization of the extrahepatic biliary tree (common hepatic duct, cystic duct, common bile duct, aberrant ducts)
Time Frame: intraoperative
|
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).
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ali Zarrinpar, MD, PhD, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2021
Primary Completion (Actual)
September 15, 2022
Study Completion (Actual)
April 1, 2023
Study Registration Dates
First Submitted
May 28, 2021
First Submitted That Met QC Criteria
June 25, 2021
First Posted (Actual)
June 28, 2021
Study Record Updates
Last Update Posted (Actual)
August 30, 2023
Last Update Submitted That Met QC Criteria
August 9, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202100388
- OCR40380 (Other Identifier: UF OnCore)
- PRO00043219 (Other Identifier: UFIRST)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We are not sharing individual participant data with other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.