Axillary Reverse Mapping (ARM)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||ARM: Axillary Reverse Mapping|
- Occurrence of lymphedema by the first year following surgery [ Time Frame: One year ] [ Designated as safety issue: No ]
- Successful identification (i.e., localization) of breast SLN and arm lymphatics [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]
- Characterization of location (typical versus variant) of arm lymphatics. [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]
- Successful protection of the arm lymphatics during SLNB and/or ALND. [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]
- Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics. [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
|No Intervention: 1||
Procedure: Axillary Reverse Mapping
During surgery, the technetium-99m sulfur colloid will be injected into the breast and the blue dye injected (if the patient is not allergic and it is not required to locate the SLN) in the patient's ipsilateral upper arm. The lymph node biopsy and/or dissection will be performed by the surgeon, according to standard practice.
Each patient will receive an injection of 1.0 mCi of technetium-99m sulfur colloid into the normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor.
If the radioactive SLN cannot be located prior to incision via gamma probe then the blue dye will be used in the breast either in the subareolar plexus or peritumorally at the discretion of the surgeon. For this contingency (expected to occur <3% of the time), the blue dye will be used in the breast (and NOT the arm), as the prime concern is locating the SLN for staging.
If the blue dye is unnecessary to find the sentinel node draining from the breast, then it will be injected dermally in the upper inner arm along the Biceps 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 either the subareolar plexus, peritumorally (intraparenchymal or dermally), or dermally in the patient's ipsilateral arm dependent upon the contingencies stated above. Site of all injections (radioactivity and/or blue dye) will be recorded.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572481
|United States, Arkansas|
|University of Arkansas For Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||V. Suzanne Klimberg, MD||University of Arkansas|