ARM: Axillary Reverse Mapping
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Assess lymphedema rates
Study Overview
Brief Summary
It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND). Therefore, mapping the drainage of the arm in addition to the drainage of the breast during the procedure would potentially decrease the incidence of arm lymphatic disruption and subsequent development of lymphedema while providing adequate axillary breast nodes needed for staging.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Axillary lymph node biopsy
Intervention: Axillary lymph node dissection (Procedure)
Sentinel lymph node biopsy
During surgery, 1.0 mCi of technetium-99m sulfur colloid will be injected into sub-dermal subareolar aspect of the affected breast. The KUMC Nuclear Medicine Department will be responsible for performing the injection of the isotope and dilution of the isotope using saline to a final volume of 4.0 ml or less.
Intervention: Injection of isotope (Procedure)
Outcomes
Primary Outcomes
Assess lymphedema rates
Time Frame: Four Years
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.
Secondary Outcomes
- Characterization of location(at time of surgery)
- Protection of the arm(at time of surgery)
- Occurrence of crossover(at time of surgery)
- Identification of breast sentinal lymph node and arm lymphatics(at time of surgery)