Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia
Recruiting
Phase 1
Phase 2
Interventional Study
Biliary Atresia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 Days – 3 Months
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 20 (estimated)
- Sponsor
- Boston Children's Hospital · Other
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About This Trial
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 measu…
Trial Locations
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Eligibility Criteria
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…
Contacts
No contact information available.