Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
This trial is active, not recruiting.
|Treatment||ultrasonic ablation device|
|Start date||March 2011|
|End date||October 2016|
|Trial size||20 participants|
|Trial identifier||NCT01331954, HIFU/BG/FA/Jan2011|
Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.
|Intervention model||single group assignment|
Reduction of breast fibroadenoma volume at ultrasonography
time frame: 12 months
Female participants at least 18 years old.
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
|Official title||Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study|
|Principal investigator||Roussanka Kovatcheva, M|
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