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

Launched by THERACLION · Apr 7, 2011

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for breast fibroadenomas, which are non-cancerous lumps in the breast. The treatment being tested is called High Intensity Focused Ultrasound (HIFU), a method that uses sound waves to target and treat the fibroadenoma without surgery. The goal of the trial is to see how effective this treatment is for women who have been diagnosed with a fibroadenoma.

To participate in the trial, women aged 65 to 74 who have one fibroadenoma that is between 1 cm and 3 cm in size may be eligible. They need to have a confirmed diagnosis based on a clinical exam, ultrasound, and, for those over 35, a mammogram showing a low-risk score. However, women who are pregnant, have a history of breast cancer, or have certain other conditions are not eligible. Participants can expect to receive the HIFU treatment and will be monitored to see how well it works. It's important to note that this trial is currently active but not recruiting new participants.

Gender

FEMALE

Eligibility criteria

• 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