Indocyanine green for diagnosing biliary atresia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1/2 interventional study in which infants under 3 months with cholestasis who are already undergoing a HIDA scan will receive an injection of indocyanine green (ICG). After ICG administration, investigators will use near-infrared imaging to look for fluorescence in the stool, because ICG is taken up by the liver and excreted in bile. Lack of stool fluorescence would indicate impaired bile flow consistent with biliary atresia. The approach aims to provide a non-radioactive, functional test of bile duct patency that could supplement existing diagnostic imaging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. age \<3 months viable infants
2. cholestasis (defined as direct bilirubin \>1)
3. undergoing diagnostic HIDA scan to evaluate for biliary atresia

Exclusion Criteria

1. kidney disease (eGFR \<60 mL/min/1.73m2)
2. grossly bloody stools
3. history of bowel surgery or disease
4. history of allergic reaction to ICG, iodine, or shellfish
5. unable to provide informed consent

Where it's running

• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  We will give eligible newborns a single IV dose of indocyanine green (ICG) to see if the dye appears in their diapers, which would indicate bile is flowing and the bile ducts are open.

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• Investigating serum FGF19 levels for predicting outcomes in biliary atresia

  This study is testing if measuring a specific protein in the blood can help doctors predict how well children with biliary atresia will do after surgery.

  Recruiting Children's Hospital of Fudan University · Shanghai, Shanghai Municipality · NCT05848310

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.