ARM: Axillary Reverse Mapping
Patients will receive an injection of 1.0 mCi of technetium-99m sulfur colloid that will be
injected into the sub-dermal subareolar aspect of the affected breast.
On the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior
to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar
plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes.
This contingency, expected to occur < 3% of the time, will be used since locating the SLN
for staging is of greater importance than the study. If radioactive isotope is sufficient to
identify the sentinel node draining from the breast, then the blue dye will be injected
dermally in the upper inner arm along the bicipital groove of the ipsilateral arm in order
to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be
injected in any of the above mentioned scenarios. The site of all injections (radioactivity
and/or blue dye) will be recorded.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess lymphedema rates
The primary objective of this study is to assess and test the lymphedema rates six times at the following intervals: Pre-surgery - baseline, at 6 months, and yearly for 4 years. Since the historical control rates are different (5% for SLNB only and 13% for ALND with or without SLNB) two tests will be performed.
Carol Connor, MD
University of Kansas
United States: Institutional Review Board
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|