Clinical Trials Directory

Trials / Completed

CompletedNCT00717886

Upper Extremity Lymphatic Mapping for Breast Cancer Patients

Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Memorial Sloan Kettering Cancer Center · Academic / Other
Sex
Female
Age
21 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
RADIATIONisosulfan blue dyeAt 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.

Timeline

Start date
2008-06-01
Primary completion
2009-10-01
Completion
2009-10-01
First posted
2008-07-18
Last updated
2015-11-20
Results posted
2015-11-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00717886. Inclusion in this directory is not an endorsement.