Actively Recruiting
Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia
Led by Boston Children's Hospital · Updated on 2026-04-06
20
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants younger than 3 months
- Diagnosed with cholestasis, defined as direct bilirubin greater than 1
- Scheduled for a diagnostic HIDA scan to evaluate for biliary atresia
You will not qualify if you...
- Kidney disease with estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73m2
- Presence of grossly bloody stools
- History of bowel surgery or bowel disease
- History of allergic reaction to Indocyanine Green (ICG), iodine, or shellfish
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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