Treatment of Breast Fibroadenoma With FastScan HIFU

Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.

In a previous european feasibility study performed at 4 sites (France and Bulgaria), 51 fibroadenomas in 42 patients were treated. The HIFU treatment was well tolerated and showed efficacy (mean volume reduction of 72.5% +/-16.7 at 12 months follow-up.

Inclusion criteria

• 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.