NCT07513038

Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 0 Days – 3 Months
• Healthy volunteers: Not accepted

Summary

Biliary atresia is a rare, progressive liver disease that only affects infants. It leads to complete obstruction and scarring of the bile duct. Current non-invasive diagnostic tests have limited sensitivity. Indocyanine Green (ICG) is a non-radioactive, fluorescent compound with several clinical applications including angiography for ophthalmologic testing, visualization during surgery, and measurement of liver function. After excitation with near infrared light (750-810 nm), ICG emits near infrared light at 850 nm, which can be detected by a special camera. ICG is taken up by the liver exclusively and excreted in the bile, where it is removed from the body in the stool. The hypothesis is that after injection of ICG, participants with biliary atresia will not have any fluorescence detected in the stool. Investigators aim to use ICG as a functional test of bile duct patency in participants with cholestasis being evaluated for biliary atresia.

Conditions

• Biliary Atresia

Interventions

Type	Name	Description
DRUG	Indocyanine Green (ICG)	One time Indocyanine Green (ICG) injection.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study