Breast Cancer, Melanoma
Conditions
Keywords
breast cancer, melanoma, sentinel lymph node biopsy, lymphadenectomy
Brief summary
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.
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.
Interventions
PROCEDUREMethylene 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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of subjects in whom a secondary echelon lymph node is identified | one year |
Countries
United States
Outcome results
None listed