Second Echelon Node Study With Methylene Blue

Not Applicable

Completed

• Conditions: Melanoma; Breast Cancer
• Interventions: Procedure: Methylene blue dye injection of sentinel lymph node

• Registration Number: NCT01823172
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-03-28
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-02
• Study First Posted: 2013-04-04
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The number of subjects in whom a secondary echelon lymph node is identified	one year

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States