Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Inclusion criteria

• Female patients 18 years or older with at least one diagnosed breast fibroadenoma.
• Diagnosis of fibroadenoma must be based on:

• clinical examination,
• women ≤ 40 years of age: ultrasound image alone; women > 40 years of age: ultrasound image and mammogram,
• histological confirmation of fibroadenoma of the breast.
• Patient's fibroadenoma size as determined by ultrasound imaging: the longest diameter is limited to 25 mm.
• Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to HIFU treatment.
• Patient must be able to understand the nature and the extent of the study and the procédures required and be willing and able to complete the screening and study procedures.
• Patient must give written informed consent (personally signed and dated) before completing any study-related procedure.

Exclusion criteria

• Patient who is pregnant or breast-feeding.
• Patient with history of ipsilateral breast cancer within 5 years prior to study inclusion or radio therapy to the target breast within 5 years prior to study inclusion.
• Patient with implant on the treated breast.
• Patient with target fibroadenoma pre-treated by cryoablation or interstitial laser therapy within 12 month before recruiting for HIFU.
• Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
• Patient participating in other studies using drugs or medical devices within 3 months prior to study inclusion or during study participation including the follow-up period.