Completed

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

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What is being tested

Methylene blue dye injection of sentinel lymph node

Procedure
Who is being recruted

Breast Diseases+11

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: March 23, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorMayo Clinic
Last updated: March 23, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

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

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine TumorsBreast NeoplasmsMelanoma

Criteria

4 inclusion criteria required to participate
Histologically confirmed invasive ductal or lobular carcinoma

Histologically confirmed primary cutaneous melanoma located on the extremity or trunk

Patient undergoing surgical treatment of breast primary and sentinel lymph node biopsy- clinically node negative

Patients with clinically stage I-II melanoma

9 exclusion criteria prevent from participating
Failure of lymphatic mapping with radioactive colloid

Inflammatory breast cancer

Melanoma located on the head or neck, uveal or mucosal

No lymph node identified in the ipsilateral breast during pathologic review of the mastectomy specimen

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Mayo Clinic in Rochester

Rochester, United StatesOpen Mayo Clinic in Rochester in Google Maps
CompletedOne Study Center