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NCT02057393 · ClinicalTrials.gov registry record · NA

Infrared Lymphangiography as a Method of Sentinel Node Identification

A NA study, sponsored by Milton S. Hershey Medical Center.

Completed
Registry status
NA
Development phase
89
Enrollment target

NCT02057393: Completed NA study, sponsored by Milton S. Hershey Medical Center.

NCT02057393 is a NA study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 89 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02057393, a NA study, has completed, sponsored by Milton S. Hershey Medical Center.

COMPLETED
Registry status
NA
Development phase
89 participants
Enrollment target

Study Summary

The initial treatment for most people with melanoma involves wide excision of the skin and sentinel node biopsy. As with other cancers, the status of the sentinel node provides important prognostic information to the patient and physician. Sentinel node biopsy was first developed using only a blue dye. Technetium99, a radioactive protein, was added later and provides the ability to image the patient and identify relevant lymph node basins. For the last 15 years or so, the standard method of SLN localization includes both tech99 and blue dye. While the rates of localization overall are excellent, these methods each have drawbacks. We are investigating a new method of finding sentinel nodes that uses a green dye that has an infrared signal. Our hypothesis is that indocyanine green (ICG) and real time lymphangiography is equivalent to technetium99 and methylene blue in identifying sentinel nodes (SLN) in patients with melanoma.

Primary Outcome

The primary outcome measure is the accuracy of indocyanine green (ICG) and real time lymphangiography to identify sentinel nodes (SLN) in patients with melanoma, compared to tech99 and methylene blue. Tech99 is considered the standard, for comparison. Accuracy is being determined by the number of sentinel nodes that are identified with ICG, compared to tech99 or methylene blue.

Interventions

  • DRUG Indocyanine green
  • DRUG Technetium99
  • DRUG Methylene blue

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2014-06
Est. Completion 2016-02
Phase NA
Milton S. Hershey Medical Center

396 total trials

What the finished NCT02057393 record still lists

NCT02057393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 3 interventions - of which Indocyanine green is the first listed.

NCT02057393 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02057393 about?

NCT02057393 is a clinical study titled "Infrared Lymphangiography as a Method of Sentinel Node Identification". The initial treatment for most people with melanoma involves wide excision of the skin and sentinel node biopsy. As with other cancers, the status of the sentinel node provides important prognostic information to the patient and physician. Sentinel node biopsy was first developed using only a blue d...

What is the current status of trial NCT02057393?

This trial is currently completed. It is a NA study. The enrollment target is 89 participants. The study started on 2014-06. Estimated completion is 2016-02.

What interventions are being tested in trial NCT02057393?

The interventions under investigation include: Indocyanine green (DRUG), Technetium99 (DRUG), Methylene blue (DRUG).

Who is sponsoring clinical trial NCT02057393?

This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02057393's enrollment target sits among peer trials

89 972nd of 2000 higher than 1,029 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT02057393, the US trial registry maintained by the National Library of Medicine. NCT02057393 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.