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Completed

NCT Number: NCT01823172

Second Echelon Node Study 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2013
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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