Indocyanine green for diagnosing biliary atresia
Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia
This test tries to see if a harmless fluorescent dye (indocyanine green) can show whether infants under 3 months with cholestasis have blocked bile ducts (biliary atresia).
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 0 Days to 3 Months |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07513038 on ClinicalTrials.gov |
What this trial studies
This is a phase 1/2 interventional study in which infants under 3 months with cholestasis who are already undergoing a HIDA scan will receive an injection of indocyanine green (ICG). After ICG administration, investigators will use near-infrared imaging to look for fluorescence in the stool, because ICG is taken up by the liver and excreted in bile. Lack of stool fluorescence would indicate impaired bile flow consistent with biliary atresia. The approach aims to provide a non-radioactive, functional test of bile duct patency that could supplement existing diagnostic imaging.
Who should consider this trial
Good fit: Infants younger than 3 months with cholestasis (direct bilirubin >1) who are undergoing diagnostic HIDA scan and who do not have kidney disease, grossly bloody stools, prior bowel disease or surgery, or known allergy to ICG/iodine/shellfish are ideal candidates.
Not a fit: Patients with significant kidney dysfunction, grossly bloody stools, prior bowel surgery or disease, known allergy to ICG/iodine/shellfish, or infants older than the enrollment age limit are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could provide a quick, non-radioactive bedside test to detect bile duct blockage and help get infants to treatment sooner.
How similar studies have performed: ICG is widely used and considered safe for surgical imaging and liver function tests, but using stool fluorescence to diagnose biliary atresia is a novel application with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.