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NCT07513038 · ClinicalTrials.gov registry record · Phase 1
Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia
A Phase 1 study, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT07513038 is a Phase 1 study that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 20 participants.
The verdict
NCT07513038, a Phase 1 study, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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.
Interventions
- DRUG Indocyanine Green (ICG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07513038
The ClinicalTrials.gov registry entry for NCT07513038 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Indocyanine Green (ICG) is the first listed.
NCT07513038 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07513038 about?
NCT07513038 is a clinical study titled "Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia". 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 ap...
What is the current status of trial NCT07513038?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-08-01. Estimated completion is 2026-12.
What interventions are being tested in trial NCT07513038?
The interventions under investigation include: Indocyanine Green (ICG) (DRUG).
Who is sponsoring clinical trial NCT07513038?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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