Feasibility of Lymphatic Mapping of Second Echelon Lymph Nodes With Methylene Blue
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Breast Cancer, Melanoma
Both
Breast Cancer, Melanoma
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 Rochester | Rochester, Minnesota 55905 |
