Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma

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 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).

Inclusion Criteria:

• Ability to understand and willingness to sign informed consent document
• Signed written informed consent
• Malignant melanoma (MM) undergoing sentinel lymph node biopsy (SNLB)
• 18 years of age or older
• Complete blood count (CBC) and metabolic panel within 6 months

Exclusion Criteria:

• History of hepatic or renal failure
• Allergy to iodine containing products
• Pregnant or may be pregnant
• Psychiatric or addictive disorders that in the opinion of the research team, may not be able to meet study requirements
• Undergoing dialysis