Using Indocyanine Green (ICG) for Biliary Atresia Diagnosis

This study is looking at a new way to diagnose biliary atresia, a rare liver disease in infants where bile ducts are blocked. We are testing a special dye called Indocyanine Green (ICG). This dye is non-radioactive and glows under a special camera. It's taken up by the liver and then leaves the body in stool. We want to see if we can detect this dye in your baby's stool 24 hours after an injection to help diagnose biliary atresia. We are looking for infants up to 3 months old who have cholestasis (high direct bilirubin) and are already having a diagnostic HIDA scan. Your baby cannot participate if they have kidney disease, bloody stools, a history of bowel surgery, or an allergy to ICG, iodine, or shellfish. The study aims to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
Participants will receive a one-time injection of Indocyanine Green (ICG). Stool will be collected and tested 24 hours after the injection.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement is taken 24 hours after the injection.

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NCT07513038

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

Recruiting
PHASE1Ages 0–3InterventionalDiagnostic
Boston Children's Hospital
~20 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:Indocyanine Green (ICG)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Indocyanine green (ICG) fluorescence in stool
Measured over 24 hours after injection
Biliary Atresia
1 sites across 1 states
Massachusetts1

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  • Indocyanine green (ICG) fluorescence in stool24 hours after injection

    We will assess if there is presence or absence of ICG fluorescence in the stool 24 hours after injection. This will be done using fluorescent imaging (Stryker) and result confirmed by two study staff.