Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indocyanine Green (ICG).
- Who it may be relevant to
- Registry conditions: Biliary Atresia. Basic parameters: 0 Days — 3 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Indocyanine Green (ICG)
One time Indocyanine Green (ICG) injection.
Primary outcome measures
- Indocyanine green (ICG) fluorescence in stool [Time frame: 24 hours after injection]
Eligibility criteria
Inclusion criteria
- age <3 months viable infants
- cholestasis (defined as direct bilirubin >1)
- undergoing diagnostic HIDA scan to evaluate for biliary atresia
Exclusion criteria
- kidney disease (eGFR <60 mL/min/1.73m2)
- grossly bloody stools
- history of bowel surgery or disease
- history of allergic reaction to ICG, iodine, or shellfish
- unable to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Identifiers
NCT: NCT07513038 · P00047206