This clinical trial compares and contrasts lymph node mapping using indocyanine green (IC-GREEN), isosulfan blue (ISB), and TSC and Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC). Study participants with malignant melanoma will undergo all 3 evaluations to assess the extent of the spread of the melanoma.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
Administered peri-tumoral and intradermally
Administered peri-tumoral and intradermally
Stanford University Hospitals and Clinics
Stanford, California, United States
Sentinel Lymph Nodes (SLN) Mapping
Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.
Time frame: Up to 1 year
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