Treatment of Breast Fibroadenoma With FastScan HIFU

• Female patients 18 years or older with one diagnosed breast fibroadenoma.

• Diagnosis of fibroadenoma must be based on :

  • clinical examination,
  • ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS (Breast Imaging, Reporting and Data System) score of this mammogram must be less than 3.
  • histologic confirmation after core needle biopsy by two independent readers (biopsy must be performed at least two weeks before therapy unless a microbiopsy has been already done less than 3 months before inclusion visit and histopathology slices are available).

• The requirements for the distance from the skin and the following regions of the fibroadenoma are:

  • ≤ 23 mm from the posterior border of the fibroadenoma
  • ≥ 5 mm from the anterior border of the fibroadenoma
  • ≥ 11mm from the focal point of the HIFU treatment. These criteria shall be evaluated immediately prior to treatment once breast is immobilized and potentially compressed
• The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance behind the focal point= 10 mm). This criterion shall only be reached in treatment conditions, once breast is immobilized and potentially compressed.
• Patient's fibroadenoma is 1 cm or greater at its largest dimension
• Fibroadenoma is palpable
• Patient has signed a written informed consent.

Exclusion Criteria:

• Patient who is pregnant or lactating.
• Patient with a BI-RADS score > 2 at the mammogram, or presence of microcalcifications within the lesion.
• Patient with history of breast cancer or history
• Patient with history of laser or radiation therapy to the target breast
• Patient with breast implants in the target breast
• Patient with a breast cyst
• Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit
• Patient participating in other trials using drugs or devices.