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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT07513038
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Biliary Atresia

Eligibility Criteria

Sex
ALL
Age
0 Days - 3 Months
Healthy Volunteers
Not accepted

Interventions

  • Indocyanine Green (ICG) — DRUG
    One time Indocyanine Green (ICG) injection.

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Indocyanine Green (ICG)
    All infants enrolled in this study will receive an injection of ICG

Primary Outcome Measure

Indocyanine green (ICG) fluorescence in stool [ Time Frame: 24 hours after injection ]

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Andrew Wehrman, MD
[email protected]
617-631-7723

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By research site
Boston Children's Hospital· Boston, MA

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