Biliary Atresia Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 3 months
Healthy Volunteers: f
View:

• age \<3 months viable infants

• cholestasis (defined as direct bilirubin \>1)

• undergoing diagnostic HIDA scan to evaluate for biliary atresia

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 20
Treatments
Experimental: Indocyanine Green (ICG)
All infants enrolled in this study will receive an injection of ICG
Related Therapeutic Areas
Sponsors
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov