NCT07513038 Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia
| NCT ID | NCT07513038 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Boston Children's Hospital |
| Condition | Biliary Atresia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-08-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07513038 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 3 Months, studying Biliary Atresia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07513038 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07513038 currently recruiting?
Yes, NCT07513038 is actively recruiting participants. Visit ClinicalTrials.gov or contact Boston Children's Hospital to inquire about joining.
Where is the NCT07513038 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07513038 clinical trial?
NCT07513038 is sponsored by Boston Children's Hospital. The trial plans to enroll 20 participants.