drugset / Trial / NCT02057393

Infrared Lymphangiography as a Method of Sentinel Node Identification

NCT02057393

Completed 89 enrolled Milton S. Hershey Medical Center
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2014-06
Primary completion
2016-01
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Indocyanine Green Diagnostic / imaging agent 0.9 ml Subcutaneous
Subject Methylene Blue Diagnostic / imaging agent 0.5 ml Subcutaneous
Subject Methylene Blue Diagnostic / imaging agent 2 ml Subcutaneous
Subject Technetium99 Unknown Subcutaneous

Indications