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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Breast Cancer, Melanoma

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Trial Information

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


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 bopsy 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

James Jakub, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

12-009929

NCT ID:

NCT01823172

Start Date:

April 2013

Completion Date:

April 2014

Related Keywords:

  • Breast Cancer
  • Melanoma
  • breast cancer
  • melanoma
  • sentinel lymph node biopsy
  • lymphadenectomy
  • Breast Neoplasms
  • Melanoma

Name

Location

Mayo Clinic in RochesterRochester, Minnesota  55905