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

RecruitingPhase 1, Phase 2Ages 0 Days - 3 MonthsAllBoston Children's Hospital
NCT07513038 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 participan

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📋 Eligibility rules (as published)
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
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What it tests

  • Indocyanine Green (ICG)
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Where

1 site
Boston Children's Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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