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NCT07250854 · ClinicalTrials.gov registry record · Early Phase 1
The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis
A Early Phase 1 study of Biliary Atresia and Kasai, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT07250854: Recruiting Early Phase 1 study of Biliary Atresia and Kasai, sponsored by University of Alabama at Birmingham.
NCT07250854 is a Early Phase 1 study of Biliary Atresia and Kasai that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 15 participants, below the 573-participant average among 7 other Biliary Atresia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07250854, a Early Phase 1 study of Biliary Atresia and Kasai, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
In infants that present with findings concerning for biliary atresia, along with other cholestatic work up which is standard, they will receive a one-time intravenous (IV) dose of Indocyanine Green (ICG). The infant's diapers will subsequently be examined for presence of the ICG, and if present, suggests bile flow. This was described as 97% accurate for assessing biliary patency and we would like to perform a similar study to assess biliary patency in the work up of neonatal cholestasis.
Primary Outcome
Measuring stool fluorescence using near infrared imaging
Conditions Studied
Interventions
- DRUG Indocyanine Green
Study Locations (1)
Alabama
- University of Alabama At Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2026-01-23 |
| Est. Completion | 2027-03 |
| Phase | Early Phase 1 |
What NCT07250854 shows while recruiting
NCT07250854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 573-participant average among 7 other Biliary Atresia trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with Biliary Atresia appearing as the primary indexed condition, and to 1 intervention - of which Indocyanine Green is the first listed.
NCT07250854 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT07250854 about?
NCT07250854 is a clinical study titled "The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis". In infants that present with findings concerning for biliary atresia, along with other cholestatic work up which is standard, they will receive a one-time intravenous (IV) dose of Indocyanine Green (ICG). The infant's diapers will subsequently be examined for presence of the ICG, and if present, sug...
What is the current status of trial NCT07250854?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2026-01-23. Estimated completion is 2027-03.
What conditions does trial NCT07250854 study?
This clinical trial studies the following conditions: Biliary Atresia, Kasai, Cholestasis in Newborn, Cholestasis in Newborn Infant.
What interventions are being tested in trial NCT07250854?
The interventions under investigation include: Indocyanine Green (DRUG).
Who is sponsoring clinical trial NCT07250854?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07250854 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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