Second Echelon Node Study With Methylene Blue

March 21, 2018 updated by: James W. Jakub, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylene Blue
1% Methylene Blue - 1 ml. Methylene blue dye injection of sentinel lymph node
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: James Jakub, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Actual)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-009929

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

no plan to share data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma

Clinical Trials on Methylene blue dye injection of sentinel lymph node

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe