Treatment of breast fibroadenoma with high intensity focused ultrasound (HIFU): a feasibility study

Background/introduction Fibroadenomas are common, benign lesions of the breast. A minority of fibroadenomas will disappear without treatment, but most increase in size or remain unchanged. Current management of patients with fibroadenomas in the United States varies on a case by case basis and includes observation or surgical excision. Many patients find their fibroadenoma bothersome, and opt for surgical excision. The objectives of this study are to evaluate the safety and feasibility of Ultrasound guided High Intensity Focused Ultrasound (USgHIFU) delivered by the Echopulse device (Theraclion, Paris) for treatment of breast fibroadenomas. General patient safety, cosmetic outcome, tumor response, patient experience, physician/operator experience, and device performance will be assessed.