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Objective Breast fibroadenomas (FAs) are common, benign, and often bothersome. Current management 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-confirmed FA were enrolled in a prospective trial, and they underwent treatment utilizing an ultrasound-guided high-intensity focused ultrasound 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 ultrasound 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 satisfied). 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 effective, safe, and well tolerated for the treatment of FAs. A larger multicenter clinical trial is currently under way.

Treatment of Breast Fibroadenoma with Ultrasound-Guided High-Intensity Focused Ultrasound Ablation: A Feasibility Study