Second Echelon Node Study With Methylene Blue

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-11-30

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.

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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.

Conditions

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Breast Cancer Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Methylene Blue

1% Methylene Blue - 1 ml. Methylene blue dye injection of sentinel lymph node

Group Type EXPERIMENTAL

Methylene blue dye injection of sentinel lymph node

Intervention Type PROCEDURE

Single arm study. Methylene blue will be injected into the 1st SLN and traced via the efferent lymphatic to the 2nd echelon lymph node.

Interventions

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Methylene blue dye injection of sentinel lymph node

Single arm study. Methylene blue will be injected into the 1st SLN and traced via the efferent lymphatic to the 2nd echelon lymph node.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No