Journal of Breast Imaging, 2019, Vol. 1, Issue 4, 316–323 doi:10.1093/jbi/wbz050 Original Research Received: December 16, 2018; Editorial Acceptance: May 2, 2019 Published Online: October 8, 2019 316 © Society of Breast Imaging 2019. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com Original Research Treatment of Breast Fibroadenoma with Ultrasound-Guided High-Intensity Focused Ultrasound Ablation: A Feasibility Study David R. Brenin, MD* , , James Patrie, MS, Jonathan Nguyen, MD, Carrie M. Rochman, MD University of Virginia Health System, Department of Surgery, Charlottesville, VA (D.R.B.); University of Virginia Health System, Department of Public Health Sciences, Charlottesville, VA (J.P.); University of Virginia Health System, Department of Radiology, Charlottesville, VA (J.N., C.M.R.) *Address correspondence to D.R.B. (e-mail: drb8x@virginia.edu) Abstract Objective: Breast fbroadenomas (FAs) are common, benign, and often bothersome. Current man- agement includes observation or surgical excision. This study evaluated the safety and feasibility of ultrasound-guided high-intensity focused ultrasound ablation for the treatment of FAs. Methods: Twenty women with a palpable, biopsy-confrmed FA were enrolled in a prospective trial, and they underwent treatment utilizing an ultrasound-guided high-intensity focused ultra- sound ablation device. Tumors were greater than 1 cm in diameter, with volumes of 0.3–10 cc. Safety, treatment experience, toxicity, cosmesis, and change in tumor size on palpation and ultra- sound measurement were obtained before and after treatment at 3, 6, and 12 months. Results: All of the 20 patients completed therapy. Pretreatment mean tumor volume was 1.8 cc (standard deviation = 1.23, range 0.57–5.7). Half of the patients reported a painful mass before treatment. All adverse events were well tolerated and transient, with the most common being mild pain, reported by 15 of 20 patients during treatment, and 14 of 20 at the day-7 postprocedure follow-up. Mean pain score during treatment was 16, and at day 7, it was 12.2, on a scale from 0 to 100 (100 = worst pain). Mean patient satisfaction was 4.4 on a scale of 1–5 (5 = most sat- isfed). Mean likelihood of recommending treatment was 4.7 (5 = most likely). At the 12-month postprocedure follow-up, the mean reduction in volume of the FA was 65.5% on ultrasound; the mass was no longer palpable in 80% of the patients; no patients reported pain; and cosmesis was rated as excellent in all patients. Conclusion: Ultrasound-guided high-intensity focused ultrasound ablation appears to be ef- fective, safe, and well tolerated for the treatment of FAs. A larger multicenter clinical trial is cur- rently under way. Key words: focused ultrasound ablation; breast fbroadenoma; high-intensity focused ultrasound. Introduction Fibroadenomas (FAs) are benign stromal tumors of the breast. They are often detected during breast self-examination or during a clin- ical breast examination performed by a health care provider. These tumors commonly present as a palpable, mobile mass, and they can be associated with tenderness. Although they are most commonly diagnosed in women under the age of 30 years, FAs are seen in women of all ages (1, 2). Downloaded from https://academic.oup.com/jbi/article/1/4/316/5583729 by guest on 26 November 2023