Second Echelon Node Study With Methylene Blue

Mayo Clinic

Status: Completed

Conditions: Breast Cancer; Melanoma

Treatments: Procedure: Methylene blue dye injection of sentinel lymph node

Study type: Interventional

Funder types: Other

Identifiers

NCT01823172

12-009929

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Methylene Blue

Experimental group

Description:

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

Treatment:

Procedure: Methylene blue dye injection of sentinel lymph node