Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study
N/A
21 Years
N/A
21 Years
N/A
Not Enrolling
Female
Breast Cancer, Axillary Lymph Node Dissection
Female
Breast Cancer, Axillary Lymph Node Dissection
Trial Information
Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study
Inclusion Criteria:
- Females with Stage II invasive breast cancer and documented axillary metastases by
core biopsy, clinical examination, or fine-needle aspiration who are scheduled to
undergo an ALND.
- Females > 21 years of age
Exclusion Criteria:
- Prior ipsilateral axillary surgery
- Prior ipsilateral axillary radiation
- Prior ipsilateral breast cancer
- Prior ipsilateral breast radiation
- Allergy to isosulfan blue dye
- History of ipsilateral upper extremity lymphedema
- Prior history of surgical excision of the upper outer quadrant of the ipsilateral
breast
- Prior history of neoadjuvant chemotherapy for current breast cancer
- Bulky axillary disease at presentation (N2)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Number and prevalence of metastases of blue nodes in the ALND specimen (nodes draining the breast).
Outcome Time Frame:
conclusion of the study
Safety Issue:
No
Principal Investigator
Leslie Montgomery, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
08-051
NCT ID:
NCT00717886
Start Date:
June 2008
Completion Date:
October 2009
Related Keywords:
- Breast Cancer
- Axillary Lymph Node Dissection
- Breast
- Lymph Nodes
- Breast Neoplasms
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
