Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 0 Days and 3 Months
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Indocyanine Green (ICG) 		All infants enrolled in this study will receive an injection of ICG
  • Drug: Indocyanine Green (ICG)
    One time Indocyanine Green (ICG) injection.

Recruiting Locations

Boston Children's Hospital
Boston, Massachusetts 02115
Contact:
Andrew Wehrman, MD
617-631-7723
andrew.wehrman@childrens.harvard.edu

More Details

Status
Recruiting
Sponsor
Boston Children's Hospital

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.