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NCT04942665 · ClinicalTrials.gov registry record · Phase 2

Low Dose ICG for Biliary Tract and Tumor Imaging

A Phase 2 study, sponsored by University of Florida.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target

NCT04942665: Completed Phase 2 study, sponsored by University of Florida.

NCT04942665 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04942665, a Phase 2 study, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target

Study Summary

Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green (ICG) allows for the intraoperative identification of liver anatomy. The investigators have new data that a much lower dose improves this visualization. Confirmation of this hypothesis would mean that ICG can be administered on the same day of surgery in order to augment real-time intraoperative visualization, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.

Primary Outcome

Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver

Interventions

  • DRUG Indocyanine green
  • DEVICE PINPOINT Endoscopic Fluorescence

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-09-15
Est. Completion 2023-04-01
Phase Phase 2
University of Florida

1,106 total trials

What the finished NCT04942665 record still lists

NCT04942665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 2 interventions - of which Indocyanine green is the first listed.

NCT04942665 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04942665 about?

NCT04942665 is a clinical study titled "Low Dose ICG for Biliary Tract and Tumor Imaging". Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green (ICG) allows for the intraoperative identification of liver anatomy. The investigators have new data that a much lower dose improves this visualization. Confirmation of this hypothesis would mean that ICG c...

What is the current status of trial NCT04942665?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-09-15. Estimated completion is 2023-04-01.

What interventions are being tested in trial NCT04942665?

The interventions under investigation include: Indocyanine green (DRUG), PINPOINT Endoscopic Fluorescence (DEVICE).

Who is sponsoring clinical trial NCT04942665?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04942665's enrollment target sits among peer trials

60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04942665, the US trial registry maintained by the National Library of Medicine. NCT04942665 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.