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

Phase 2RecruitingNCT07513038

Boston Children's Hospital20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Biliary Atresia

Interventions

Eligibility

Sex: ALLMin age: 0 DaysMax age: 3 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Indocyanine green (ICG) fluorescence in stool

We will assess if there is presence or absence of ICG fluorescence in the stool 24 hours after injection. This will be done using fluorescent imaging (Stryker) and result confirmed by two study staff.

Time frame: 24 hours after injection