Adults 18 to 80, any sex, with Cholecystitis or Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity RatioPrimary· intraoperative, average of 2 hours
Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver
Group
Value
95% CI
Low Dose
2.7
1.5 – 4.2
Standard Dose
0.7
0.6 – 0.8
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White LightSecondary· 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).
Group
Value
95% CI
Low Dose
3.4
± 1.3
Standard Dose
3.1
± 1.0
Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity RatioSecondary· 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
Group
Value
95% CI
Low Dose
6.1
4.9 – 10.5
Standard Dose
2.7
2.4 – 3.0
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)Secondary· 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).
Common Hepatic Duct
Group
Value
95% CI
Low Dose
3.6
± 1.4
Standard Dose
2.8
± 1.3
Cystic Duct
Group
Value
95% CI
Low Dose
3.6
± 1.3
Standard Dose
3.5
± 1.2
Common Bile Duct
Group
Value
95% CI
Low Dose
3.6
± 1.3
Standard Dose
3.1
± 1.3
Aberrant Duct
Group
Value
95% CI
Low Dose
2.8
± 1.3
Standard Dose
2.3
± 0.4
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT06164392 — Evaluation of Neuroma Perfusion with Indocyanine Green Fluorescence Angiography
· Phase 4
· withdrawn
NCT06169735 — Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation
· Phase 4
· recruiting
NCT06322862 — FLuorescence Guided Assessment of Mesenteric Ischemia in Emergency Surgery
· NA
· recruiting
NCT06227338 — ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study
· NA
· recruiting
NCT06939946 — Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)
· Phase 1
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Florida
Last refreshed: 30 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04942665.