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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07513038

Enrollment

Registered

2026-04-06

Start date

2024-08-01

Completion date

2026-12-01

Last updated

2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Atresia

Brief summary

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

DRUGIndocyanine Green (ICG)

One time Indocyanine Green (ICG) injection.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Days to 3 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Indocyanine green (ICG) fluorescence in stool	24 hours after injection	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026