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ARM: Axillary Reverse Mapping

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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.

Inclusion Criteria:

- 18 - 100 years old

- Not pregnant or breastfeeding

- Diagnosis of breast cancer requiring LN evaluation for ipsilateral or contralateral
breast or prophylactic mastectomy

- Willing participation after obtaining informed consent

Exclusion Criteria:

- < 18 or > 100 years of age

- Pregnant or breastfeeding

- Blue dye allergy

- Cosmetic allergy

- History of primary lymphedema

- Prior breast augmentation

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess lymphedema rates

Outcome Description:

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.

Outcome Time Frame:

Four Years

Safety Issue:


Principal Investigator

Carol Connor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Institutional Review Board

Study ID:




Start Date:

September 2009

Completion Date:

February 2014

Related Keywords:

  • Breast Cancer
  • Sentinel lymph node biopsy
  • Axillary lymph node dissection
  • Prevention of lymphedema
  • Breast Neoplasms



University of Kansas Medical CenterKansas City, Kansas  66160-7353