Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
While RFA alone is not approved for tumor destruction in breast it is FDA-approved for
ablation of soft tissue after the breast cancer is removed. This study seeks to remove the
tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site
instead of removing more tissue. The primary short-term goal is to obviate the need for
re-excision in the event of close or positive margins (< 3 mm) which occurs on average in
~40 percent of the cases. Permanent pathology is only an estimation of margin status since
90% of recurrences occur at the site of the original lumpectomy. RFA ensures a sterilized
margin regardless of the accuracy of the permanent pathology.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Final surgical pathology review
V. Suzanne Klimberg, M.D.
University of Arkansas
United States: Institutional Review Board
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|