Recruiting
Phase 1
Phase 2

Indocyanine Green

Sponsor:

Boston Children's Hospital

Code:

NCT07513038

Conditions

Biliary Atresia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Indocyanine Green (ICG)

Study Details

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.

Conditions

Biliary Atresia

Study ID

NCT07513038

Start date

Aug 1, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Indocyanine Green (ICG)

All infants enrolled in this study will receive an injection of ICG

Interventions

Indocyanine Green (ICG)

One time Indocyanine Green (ICG) injection.

Primary outcome measure

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

Central Contacts and Locations

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

More Information

Sponsor

Boston Children's Hospital

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-04-06.