Using high-intensity focused ultrasound to treat breast fibroadenoma

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

This study is testing a new non-surgical treatment using high-energy ultrasound to see if it can safely shrink breast fibroadenomas.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Theraclion (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 4 sites (New York, New York and 3 other locations)
• Trial ID: NCT03044054 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of high-intensity focused ultrasound (HIFU) for treating breast fibroadenoma. The Echopulse device is specifically designed for this purpose, utilizing high-energy ultrasound to rapidly heat targeted tissue to induce coagulation and necrosis. This non-surgical approach aims to provide an effective alternative to traditional surgical methods for managing fibroadenomas.

Who should consider this trial

Good fit: Ideal candidates include female patients aged 18 and older diagnosed with breast fibroadenoma who meet specific imaging and biopsy criteria.

Not a fit: Patients with fibroadenomas that do not meet the size or location criteria, or those who are not candidates for surgery, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a non-invasive option for patients with breast fibroadenoma, reducing the need for surgery.

How similar studies have performed: Other studies using HIFU for similar conditions have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Female patients 18 years or older diagnosed with breast fibroadenoma and presenting at least one fibroadenoma.
2. Diagnosis of fibroadenoma must be based on:

   1. Clinical examination
   2. 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.
   3. Histologic confirmation by core needle biopsy.
3. Patient is a candidate for the surgery.
4. 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.
5. 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.
6. The fibroadenoma is 1 cm or greater at its largest dimension and no less than 7.5 mm in the anterior-posterior dimension (measured by ultrasound). Focal point for HIFU treatment must also be at least 3 mm from any border of the fibroadenoma.
7. Patient's fibroadenoma size is greater or equal to 0.2 cc and less than 10 cc in volume (measured by ultrasound on the day of the procedure).
8. Fibroadenoma is palpable.
9. Pain ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days
10. Anxiety ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days
11. Patient has signed a written informed consent.

Exclusion Criteria:

1. Patient is pregnant or nursing.
2. 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.
3. Patient with history of breast cancer or history of laser or radiation therapy to the target breast.
4. Patient with breast implants in the target breast.
5. Patient with a breast cyst within the fibroadenoma to be treated.
6. Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
7. Patient participating in another clinical trial involving an investigational drug, device or biologic.

Where this trial is running

New York, New York and 3 other locations

• Bellevue Hospital Center — New York, New York, United States (Completed)
• New York Columbia University Medical Center — New York, New York, United States (Completed)
• Montefiore-Einstein Center for Cancer Care — New York, New York, United States (Completed)
• University of Virginia Health system — Charlottesville, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Michel NUTA, MD

Conditions Breast Fibroadenoma; HIFU