Second Echelon Node Study With Methylene Blue

Study Overview
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Brief Summary
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The investigators plan to study the ability to identify the lymph nodes beyond the sentinel lymph node that may harbor cancer using methylene blue dye.

Detailed Description
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After lymphatic mapping of the SLN with Tc-99 sulfur colloid only, the second-echelon lymphatic mapping was then performed with methylene blue dye by injecting the SLN with 0.05-0.10 cc non dilute methylene blue and tracing via the efferent lymphatic channel to the second echelon lymph node (Figure 1). For our initial patients a 27 gauge needle and 3cc syringe was utilized but this was modified over the study to a 30 gauge needle and 1cc syringe. The blue efferent lymphatic was traced with minimal spreading of the surrounding tissue to visualize its drainage into the next lymph node(s). A second echelon lymph node was considered any blue lymph node or any lymph node with blue dye leading directly into it. The number of second echelon lymph nodes was recorded. The second-echelon lymph node(s) was not removed.

Official Title
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Feasibility of Lymphatic Mapping of Second Echelon Lymph Nodes With Methylene Blue

Conditions
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Breast Cancer, Melanoma

Intervention / Treatment
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* Procedure: Methylene blue dye injection of sentinel lymph node


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed primary cutaneous melanoma located on the extremity or trunk Patients with clinically stage I-II melanoma Histologically confirmed invasive ductal or lobular carcinoma Patient undergoing surgical treatment of breast primary and sentinel lymph node biopsy- clinically node negative Exclusion Criteria: Melanoma located on the head or neck, uveal or mucosal Previous surgery or radiation in or near the sentinel lymph node biopsy nodal basin Preoperative biopsy proven regional lymph node involvement Failure of lymphatic mapping with radioactive colloid Women who are pregnant or nursing Prior ipsilateral axillary surgery or radiation Inflammatory breast cancer No lymph node identified in the ipsilateral breast during pathologic review of the mastectomy specimen Stage IV breast cancer

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylene Blue<br>1% Methylene Blue - 1 ml. Methylene blue dye injection of sentinel lymph node | Procedure: Methylene blue dye injection of sentinel lymph node<br>* Single arm study. Methylene blue will be injected into the 1st SLN and traced via the efferent lymphatic to the 2nd echelon lymph node.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects in whom a secondary echelon lymph node is identified |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, melanoma, sentinel lymph node biopsy, lymphadenectomy