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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 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.

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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.

Interventions

  • DRUG Indocyanine Green

Study Locations (1)

Alabama

  • University of Alabama At Birmingham - Birmingham

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2026-01-23
Est. Completion 2027-03
Phase Early Phase 1

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT07250854

The ClinicalTrials.gov registry entry for NCT07250854 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 573-participant average among 7 other Biliary Atresia trials with a reported enrollment target (97% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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