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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Testing the Efficacy of Indocyanine Green Imaging (ICG-SPY) in the Identification of Sentinel Lymph Nodes (SLN) in Patients With Malignant Melanoma

Conditions
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Recurrent Melanoma

Intervention / Treatment
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* Drug: Indocyanine green solution
* Drug: Isosulfan blue (ISB)
* Diagnostic Test: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sentinel Lymph Node (SLN) Detection<br>All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective. | Drug: Indocyanine green solution<br>* Administered peri-tumoral and intradermally<br>* Other names: ICG solution;Drug: Isosulfan blue (ISB)<br>* Administered peri-tumoral and intradermally<br>* Other names: N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide;Diagnostic Test: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)<br> <br> * Other names: TSC lymph node mapping;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 1 year |