20 Participants NeededMy employer runs this trial

Indocyanine Green for Biliary Atresia

Age: < 18
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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 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.

Are You a Good Fit for This Trial?

Inclusion Criteria

2. cholestasis (defined as direct bilirubin \>1)
I am a baby younger than 3 months old and healthy enough to participate.
3. undergoing diagnostic HIDA scan to evaluate for biliary atresia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an injection of Indocyanine Green (ICG) to assess bile duct patency

1 day
1 visit (in-person)

Follow-up

Participants are monitored for the presence or absence of ICG fluorescence in the stool

24 hours
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Indocyanine Green (ICG)

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Indocyanine Green (ICG)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+