Intraoperative Mapping of Regional Lymphatics Draining the Primary Site of Melanoma Using Isosulfan Blue

Study Overview
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Brief Summary
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The purpose of this study is to determine whether we can consistently identify the first lymph node (the sentinel node) draining your melanoma.

Detailed Description
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The issue of elective lymph node dissection (LND) in the management of melanoma patients with clinically negative nodes remains controversial. The concept of elective LND is attractive because it provides the opportunity to detect and remove occult micrometastases before they become clinically apparent. Numerous retrospective analyses have consistently shown a 15-20% long term survival advantage in patients undergoing elective LND who are found to have positive nodes, compared to those undergoing therapeutic LND for clinically positive nodes. The majority of patients undergoing elective LND however, do not have lymph node involvement, and the impact of removal of these negative nodes on the survival of these patients is unknown. The substantial morbidity of these procedures has led to the conduct of a number of important prospective randomized trials designed to define the impact of elective LND on the survival of patients with clinically node negative melanoma. In 1982, the World Health Organization reported on the end results of 553 The primary objective of this protocol is to establish the feasibility of lymph node mapping, using preoperative lymphoscintigraphy and intraoperative blue dye injection to detect the sentinel node in patients at risk for regional lymph node metastasis from their primary melanoma.

Official Title
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Intraoperative Mapping of Regional Lymphatics Draining the Primary Site of Melanoma Using Isosulfan Blue

Conditions
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Melanoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary melanomas Clark III and Breslow thickness > 1 mm, or Clark IV-V and any Breslow thickness clinically negative regional nodes Exclusion Criteria: previous definitive wide local excision of the primary melanoma with skin graft an inflammatory lesion in the area of the primary melanoma that is likely to drain to the same nodal basin pregnancy
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical<br>Patients with primary melanomas Clark III and Breslow thickness > 1 mm, or Clark IV-V and any Breslow thickness, and clinically negative regional nodes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This is a trial to assess the feasibility of the technique of identifying the sentinel node using the technique of lymphatic mapping as described by Morton. The primary endpoint of the trial will be success or failure in identifying the sentinel node. |  | 18 years 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, Negative regional lymph nodes, Primary melanomas Clark III and Breslow thickness > 1 mm, or Clark, IV-V and any Breslow thickness, and clinically negative regional nodes