Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU

High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)

The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..

Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.

Inclusion Criteria:

• Patients >18 years of age
• Fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on patients <25 and ultrasound plus core-biopsy in patients >25 (Graded B2 or less)
• Visible on ultrasound (Graded U2/U3)
• Definitive diagnosis of fibroadenomata confirmed by the Breast multi-disciplinary team meeting (MDT).

Exclusion Criteria:

• Lesion with atypia or suspicion of phyllodes (Graded B3 or greater)
• Pregnant or lactating women
• History of laser or radiation therapy to the targeted breast