Second Echelon Node Study With Methylene Blue

NCT01823172 | Completed

• 1 other identifier: 12-009929
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Melanoma

Keywords

breast cancer; melanoma; sentinel lymph node biopsy; lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• The number of subjects in whom a secondary echelon lymph node is identified

  one year

Study Arms (1)

Methylene Blue

EXPERIMENTAL

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

Procedure: Methylene blue dye injection of sentinel lymph node

Interventions

Methylene blue dye injection of sentinel lymph node 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.

Methylene Blue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Study Officials

• James Jakub, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Breast and Melanoma Surgery Section Head

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 4, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)