High-intensity focused ultrasound for small invasive breast tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Institut Bergonie
  Bordeaux, France Recruiting

Study contacts

• Study coordinator: Jean PALUSSIERE, MD
• Email: j.palussiere@bordeaux.unicancer.fr
• Phone: +33 5 56 33 37 50

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.