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NCT01884584 · ClinicalTrials.gov registry record · Phase 1

Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer

A Phase 1 study, sponsored by Emory University.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT01884584: Completed Phase 1 study, sponsored by Emory University.

NCT01884584 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01884584, a Phase 1 study, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

The surgeon may remove a very small amount of additional tissue compared to what would be removed if you were not enrolled in the study. This tissue may prove to contain tumor or it may contain normal tissue. The surgical cavity will be examined by a special laser pen after the tumor is removed, and if areas of fluorescence are seen, that may indicate tumor cells where the ICG dye collected are still remaining and the surgeon would then remove those. After the tumor and the tissue around it are removed and sent to the laboratory, the tissue may be examined using that same laser pen to see where the cancer cells are and compare that to what the laboratory sees when it looks at the tumor and tissue with a microscope. It is hoped that what the dye shows and what is seen with the microscope will be alike.

Primary Outcome

Examine the resected tissue to determine whether ICG is sensitive to tumor detection (i.e., whether ICG accumulates in tumor) and whether ICG is specific for tumor (i.e., whether ICG accumulates in normal tissue).

Interventions

  • DRUG Indocyanine green (ICG)

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2012-06
Est. Completion 2015-01
Phase Phase 1
Emory University

1,208 total trials

What the finished NCT01884584 record still lists

NCT01884584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 1 intervention - of which Indocyanine green (ICG) is the first listed.

NCT01884584 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01884584 about?

NCT01884584 is a clinical study titled "Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer". The surgeon may remove a very small amount of additional tissue compared to what would be removed if you were not enrolled in the study. This tissue may prove to contain tumor or it may contain normal tissue. The surgical cavity will be examined by a special laser pen after the tumor is removed, and...

What is the current status of trial NCT01884584?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-06. Estimated completion is 2015-01.

What interventions are being tested in trial NCT01884584?

The interventions under investigation include: Indocyanine green (ICG) (DRUG).

Who is sponsoring clinical trial NCT01884584?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01884584's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01884584, the US trial registry maintained by the National Library of Medicine. NCT01884584 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.