Stage IV Melanoma Clinical Trial
Official title:
Testing the Efficacy of Indocyanine Green Imaging ( ICG-SPY ) in the Identification of Sentinel Lymph Nodes ( SLN ) in Patients With Malignant Melanoma
This clinical trial studies lymph node mapping using indocyanine green solution in diagnosing patients with malignant melanoma. Diagnostic procedures, such as lymph node mapping using indocyanine green solution, may help find out how far the melanoma has spread and may help in planning cancer treatment.
PRIMARY OBJECTIVES:
I. To show that indocyanine green (ICG) (indocyanine green solution) is equal to both
isosulfan blue (ISB) and technetium Tc 99m sulfur colloid (TSC) and will allow all lymph
node mapping to occur in the operating room (OR).
OUTLINE:
Patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine
green solution. During surgery, patients undergo identification of the sentinel lymph node
and imaging using a laser with videocamera (SPY Elite camera).
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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