Hepatocellular Carcinoma Clinical Trial
— ICGOfficial title:
Low Dose ICG for Near-infrared Fluorescence Imaging of Biliary Tract and Tumors
Verified date | August 2023 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 1, 2023 |
Est. primary completion date | September 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida Health Shands | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Society of University Surgeons |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light | 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 | |
Secondary | Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio | 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 | |
Secondary | Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts) | 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 |
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