CompletedNot Applicable

Treatment of Breast Fibroadenoma Targeted Tissue With HIFU

United States113 participantsStarted 2017-01

Plain-language summary

This study evaluates the efficacy and the safety of the HIFU for the treatment of breast fibroadenoma.

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Female patients 18 years or older diagnosed with breast fibroadenoma and presenting at least one fibroadenoma.
✓. Diagnosis of fibroadenoma must be based on:
✓. Clinical examination
✓. Ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS score of this mammogram must be 2 or 3. BI-RADS score of 4 is eligible if biopsy indicates fibroadenoma with concordance.
✓. Histologic confirmation by core needle biopsy.
✓. Patient is a candidate for the surgery.
✓. The fibroadenoma treatment volume must be at least 5 mm and no more than 26 mm from the skin. This criterion should be evaluated immediately prior treatment, once the breast is immobilized and potentially compressed.
✓. The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance from the posterior wall of the fibroadenoma must be at least 10 mm). This criterion shall be evaluated immediately prior to treatment, once breast is immobilized and potentially compressed.

✕. Patient is pregnant or nursing.
✕. Presence of calcified fibroadenoma. Calcification will be determined with mammography. In women \> 35 years old, the diagnostic mammogram should be evaluated for calcification. In women ≤ 35 years old, a single view mammogram of the affected breast is sufficient for evaluation of calcification. Women ≤ 35 years old will be excluded based on the findings of calcification on a single view mammogram.
✕. Patient with history of breast cancer or history of laser or radiation therapy to the target breast.
✕. Patient with breast implants in the target breast.
✕. Patient with a breast cyst within the fibroadenoma to be treated.
✕. Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
✕. Patient participating in another clinical trial involving an investigational drug, device or biologic.

Pain level assessment

Timeframe: 12 Months

Anxiety level assessment

Timeframe: 12 Months

Volume assessment

Timeframe: 12 Months

NCT IDNCT03044054

SponsorTheraclion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Female patients 18 years or older diagnosed with breast fibroadenoma and presenting at least one fibroadenoma.
✓. Diagnosis of fibroadenoma must be based on:
✓. Clinical examination
✓. Ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS score of this mammogram must be 2 or 3. BI-RADS score of 4 is eligible if biopsy indicates fibroadenoma with concordance.
✓. Histologic confirmation by core needle biopsy.
✓. Patient is a candidate for the surgery.
✓. The fibroadenoma treatment volume must be at least 5 mm and no more than 26 mm from the skin. This criterion should be evaluated immediately prior treatment, once the breast is immobilized and potentially compressed.
✓. The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance from the posterior wall of the fibroadenoma must be at least 10 mm). This criterion shall be evaluated immediately prior to treatment, once breast is immobilized and potentially compressed.

✕. Patient is pregnant or nursing.
✕. Presence of calcified fibroadenoma. Calcification will be determined with mammography. In women \> 35 years old, the diagnostic mammogram should be evaluated for calcification. In women ≤ 35 years old, a single view mammogram of the affected breast is sufficient for evaluation of calcification. Women ≤ 35 years old will be excluded based on the findings of calcification on a single view mammogram.
✕. Patient with history of breast cancer or history of laser or radiation therapy to the target breast.
✕. Patient with breast implants in the target breast.
✕. Patient with a breast cyst within the fibroadenoma to be treated.
✕. Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
✕. Patient participating in another clinical trial involving an investigational drug, device or biologic.