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ARM: Axillary Reverse Mapping

Phase 2
18 Years
Open (Enrolling)
Cancer of the Breast

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Trial Information

ARM: Axillary Reverse Mapping

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Occurrence of lymphedema by the first year following surgery

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

V. Suzanne Klimberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas


United States: Institutional Review Board

Study ID:

UAMS 78076



Start Date:

May 2007

Completion Date:

May 2015

Related Keywords:

  • Cancer of the Breast
  • Sentinel Lymph Node Biopsy
  • Axillary Node Dissection
  • Prevention of lymphedema
  • Prevention of neuroma
  • Prevention of seroma
  • Breast Neoplasms



University of Arkansas for Medical Sciences Little Rock, Arkansas  72205