This trial is active, not recruiting.

Condition cancer of the breast
Treatment axillary reverse mapping
Phase phase 2
Sponsor University of Arkansas
Start date May 2007
End date May 2017
Trial size 1000 participants
Trial identifier NCT00572481, UAMS 78076


We hypothesize that variations in anatomic location of the arm lymphatic drainage system put the arm lymphatics at risk for disruption during a SLNB and / or ALND. Therefore, mapping the drainage of the arm during the procedure would decrease the likelihood of inadvertent disruption of the lymphatics and the subsequent development of lymphedema. A combination of radioactivity and blue dye will be used.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
(No Intervention)
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.

Primary Outcomes

Occurrence of lymphedema by the first year following surgery
time frame: One year

Secondary Outcomes

Successful identification (i.e., localization) of breast SLN and arm lymphatics
time frame: Time of surgery
Characterization of location (typical versus variant) of arm lymphatics.
time frame: Time of surgery
Successful protection of the arm lymphatics during SLNB and/or ALND.
time frame: Time of surgery
Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics.
time frame: Time of surgery

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 18-100 years old - Not pregnant or breastfeeding - Breast cancer requiring lymph node evaluation for the ipsilateral or contralateral breast OR prophylactic mastectomy - Willing participation following an informed consent process Exclusion Criteria: - Patient < 18 y/o or > 100 y/o - Pregnant or breastfeeding - If a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis.

Additional Information

Official title ARM: Axillary Reverse Mapping
Principal investigator V. Suzanne Klimberg, MD
Description Mapping Procedure: 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Arkansas.