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Reverse Axillary Mapping as a Lymphedema Prevention Strategy in Breast Radiation Treatment Planning

Trial Status: Active

This study investigates axillary reverse mapping in preventing lymphedema in patients undergoing breast radiation treatment planning. Axillary reverse mapping is a technique that can be used during radiation treatment to identify the upper extremity lymphatics in patients with breast cancer. This technique has been used during breast cancer surgery to help surgeons identify and preserve the upper extremity lymphatic in order to lower the chances of lymphedema (swelling). This study is being done to examine whether axillary reverse mapping can be used during radiation treatment planning to identify and preserve the upper extremity lymphatic in order to lower the chances of lymphedema (swelling).

Inclusion Criteria

  • De novo presentation of post-operative (lumpectomy or mastectomy) female breast cancer patients to receive radiation to the whole breast or chest wall and the regional nodes. Patients who have received a sentinel lymph node (SLN) biopsy or an axillary lymph node dissection (ALND) will be eligible
  • Informed consent obtained

Exclusion Criteria

  • Prisoners
  • Patients with metastatic breast cancer
  • Documented allergy to iodinated contrast
  • Prior breast or axillary surgeries or radiation
  • Pregnant women
  • Patients with contraindications for iodinated contrast

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Dana Lynne Casey
Phone: 984-974-0400

PRIMARY OBJECTIVE:

I. To investigate whether axillary reverse mapping (ARM) can be used to delineate the upper extremity lymphatic (UEL) during the radiation treatment planning process.

SECONDARY OBJECTIVES:

I. To evaluate the maximum dose in units of gray delivered to the UEL (Dmax), minimum dose delivered to the UEL (Dmin), mean dose delivered to the UEL (Dmean), minimum dose delivered to 25% of the UEL (D25%), and minimum dose delivered to 75% of the UELD (D75%) delivered to the UEL during routine radiation treatment planning and whether there is any relationship to lymphedema rates at the pre-specified time points.

II. To determine whether it is hypothetically possible to safely modify radiation fields to reduce the dose (e.g. Dmin, Dmean, and Dmax) to the UELs while maintaining targeting coverage.

OUTLINE:

Patients receive iodinated contrast via injection after standard computed tomography (CT) simulation. Patients then undergo a second CT simulation 3 minutes after injection. Patients also undergo measurement of the circumference of upper and lower arms at 6, 12, 24, 36, and 60 months after treatment.

Trial Phase Phase NA

Trial Type Screening

Lead Organization
UNC Lineberger Comprehensive Cancer Center

Principal Investigator
Dana Lynne Casey

  • Primary ID LCCC1934
  • Secondary IDs NCI-2020-08327
  • Clinicaltrials.gov ID NCT04292860