High-intensity focused ultrasound for small invasive breast tumors

High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study (Breast Resection By HIFU)

This test uses high-intensity focused ultrasound to destroy small invasive ductal breast cancers in women before their planned surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Institut Bergonié (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Bordeaux)
• Trial ID: NCT03342625 on ClinicalTrials.gov

What this trial studies

This is a single-center prospective pilot enrolling up to 15 women with MRI-visible invasive ductal breast cancer ≤15 mm and clinically node-negative status. Participants undergo HIFU ablation under local anesthesia and sedation, followed by partial or total mastectomy within about a week so the removed tissue can be examined for treatment effect using histology. The primary outcome is histological evidence of tumor ablation; if no successes occur the trial will stop, while any successes prompt review by an independent data monitoring committee to consider further study. The protocol excludes lobular carcinoma, DCIS, bilateral or palpable tumors, lesions too close to skin, and patients with bra cup size A or contraindications to MRI.

Who should consider this trial

Good fit: Women with histologically proven invasive ductal carcinoma that is MRI-visible, unifocal or limited multifocal, ≤15 mm on ultrasound, clinically N0, and with bra cup size B or larger are ideal candidates.

Not a fit: Patients with lobular carcinoma or pure DCIS, bilateral or palpable tumors, lesions >15 mm or too close to the skin, MRI‑occult lesions, or bra cup size A are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, HIFU could provide a minimally invasive, non‑ionizing option to destroy small breast cancers, reducing recovery time and treatment-related complications.

How similar studies have performed: Small feasibility studies have shown that HIFU can achieve focal tumor ablation in breast cancer, but robust randomized evidence and long-term outcomes remain limited.

Eligibility criteria

Inclusion Criteria :

1. Histologically proven infiltrating ductal carcinoma with the analysis of hormone receptors, tumor grade, Her-2 expression.
2. T0 lesion, unifocal or plurifocal, with or without micro-calcifications associated, measuring 15 mm maximum major axis on ultrasound.
3. Clinical N0.
4. Bra cup size greater than or equal to B.
5. Markable and identifiable lesion in MRI.
6. Indication of partial or total mastectomy in case of multifocal lesions or extensive calcification associated with axillary surgery.
7. Breast assessment performed by a referent radiologist: Mammography, ultrasound, clinical examination.
8. No contraindication to MRI.

Exclusion Criteria :

1. Infiltrating lobular carcinoma and Pure ductal carcinoma in situ.
2. Bilateral lesion.
3. Non-detectable MRI lesions, within 10 mm of the skin, greater than 15 mm on ultrasound.
4. Unifocal palpable tumor.
5. Cup size bra equal to A.
6. Cutaneous lesion on the breast to be treated by HIFU.
7. Impossibility of ventral decubitus immobility, extended arm, during 1 hour.
8. Pregnant or postpartum patient.
9. Patient participating in another interventional clinical trial within 30 days of enrollment and during the trial.

Where this trial is running

Bordeaux

• Institut Bergonie — Bordeaux, France (Recruiting)

Study contacts

• Study coordinator: Jean PALUSSIERE, MD

Conditions Breast Cancer Female; High intensity focused ultrasound