Upper Extremity Lymphatic Mapping for Breast Cancer Patients
This study is being done to see if lymph nodes that drain the arm also drain the breast. An axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are removed. They are then examined to see if they have cancer cells. Removing these lymph nodes has some side effects. The most common is lymphedema. This is the build-up of fluid in the arm. This study will tell us if it may be possible in the future to identify lymph nodes that just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future patients.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study|
- Number and prevalence of metastases of blue nodes in the ALND specimen (nodes draining the breast). [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- Number and prevalence of metastases of radioactive nodes in the ALND specimen (nodes draining the ipsilateral upper extremity). [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- Number and prevalence of metastases of blue and radioactive nodes in the ALND specimen (nodes draining both the breast and the ipsilateral upper extremity). [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- Number and prevalence of metastases of nodes that are neither blue nor radioactive. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
Radiation: isosulfan blue dye
At the time of surgery, each patient will undergo a subareolar injection of isosulfan blue dye into the ipsilateral breast as routinely performed during a sentinel lymph node mapping for breast cancer. The surgeon will then perform an axillary lymph node dissection in the usual, routine manner. The above differs from standard of care in that patients scheduled for an upfront axillary dissection do not routinely undergo sentinel lymph node mapping- therefore these patients would not normally get any isotope or TSC injections since they already need an ALND. Second, standard sentinel lymph node mapping involves injection of TSC into the affected breast the day prior to surgery or 3 hours before surgery versus injection of TSC into the ipsilateral upper extremity. The protocol specifies "day of" mapping for patient convenience.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717886
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Leslie Montgomery, MD||Memorial Sloan-Kettering Cancer Center|