Axillary Reverse Mapping
Cancer of the Breast
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 1000 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
Sentinel Lymph Node Biopsy Only
Axillary Reverse Mapping
Procedure: Axillary Reverse Mapping
Full Axillary Lymph Node Dissection
Axillary Reverse Mapping
Procedure: Axillary Reverse Mapping
Axillary Reverse Mapping PROCEDURE
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Occurrence of lymphedema by the first year following surgery
Time frame: One year
An occurrence will consist of an increase of 20% or more in ipsilateral arm volume over the pre-surgery volume, and be accompanied by a confirmatory diagnosis of lymphedema from the UAMS lymphedema clinic.
Secondary measures
Successful identification (i.e., localization) of breast SLN and arm lymphatics
Time frame: Time of surgery
successful localization of one or more lymph nodes to which the peritumoral breast region drains
Characterization of location (typical versus variant) of arm lymphatics.
Time frame: Time of surgery
brief location details will also be collected.
Successful protection of the arm lymphatics during SLNB and/or ALND.
Time frame: Time of surgery
successful avoidance of resection and/or successful preservation of structural integrity of arm lymphatics during the surgical procedure.
Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics.
Time frame: Time of surgery
A crossover event will consist of identification of one or more lymph nodes that are both focally radioactive following peritumoral Tc99m injection and noticeably stained blue following ipsilateral arm injection with Lymphazurin.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
University of Arkansas For Medical SciencesLittle Rock, Arkansas, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- University of Arkansas
- Study start
- 2007-05 Actual
- Primary completion
- 2027-10 Estimated
- Study completion
- 2028-11 Estimated
- First posted
- Dec 13, 2007 Estimated
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
ARM: Axillary Reverse Mapping, A Prospective Study
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026