Clinical trial · Interventional
Low Dose ICG for Biliary Tract and Tumor Imaging
Low Dose ICG for Near-infrared Fluorescence Imaging of Biliary Tract and Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholecystitis | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green | Drug | — | UNRESOLVED |
| PINPOINT Endoscopic Fluorescence | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low Dose
- description
- Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.
- interventionNames
- Drug: Indocyanine green
- Device: PINPOINT Endoscopic Fluorescence
- type
- PLACEBO_COMPARATOR
- label
- Standard Dose
- description
- Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV.
- interventionNames
- Drug: Indocyanine green
- Device: PINPOINT Endoscopic Fluorescence
Primary outcomes (1)
- measure
- Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLadd 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