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

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study

Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.

Inclusion Criteria:

• One breast fibroadenoma with diagnosis based on:

  • Clinical examination
  • Ultrasound image
  • For women older than 35 years: mammogram with BI-RADS score < 3
  • Histologic confirmation by two independent readers

• Fibroadenoma size between 1 cm and 3 cm at its largest dimension (measured by ultrasound)

Exclusion Criteria:

• Patient pregnant or lactating
• Bi-RADS score > 2 at the mammogram, or microcalcifications within the lesion.
• History of breast cancer or history of laser or radiation therapy to the target breast
• Breast implants
• Breast cyst
• Fibroadenoma not clearly visible on the ultrasound images (in B mode)
• Patient participating in other trials using drugs or devices