Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia (NCT07513038) | Clinical Trial Compass
RecruitingPhase 1/2
Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia
United States20 participantsStarted 2024-08-01
Plain-language 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.
Who can participate
Age range
0 Days – 3 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. age \<3 months viable infants
. cholestasis (defined as direct bilirubin \>1)
. undergoing diagnostic HIDA scan to evaluate for biliary atresia
Exclusion criteria
. kidney disease (eGFR \<60 mL/min/1.73m2)
. grossly bloody stools
. history of bowel surgery or disease
. history of allergic reaction to ICG, iodine, or shellfish
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.