Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU) (NCT01331954) | Clinical Trial Compass
UnknownNot Applicable
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
Bulgaria20 participantsStarted 2011-03
Plain-language summary
Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Reduction of breast fibroadenoma volume at ultrasonography