High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study
Recruiting now · Not applicable
Conditions studied: Breast Cancer Female
In brief
Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.
Key facts
- Study ID
- NCT03342625
- Run by
- Institut Bergonié
- People needed
- 15
- Starts
- 2018-06-07
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2025-10-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically proven infiltrating ductal carcinoma with the analysis of hormone receptors, tumor grade, Her-2 expression.
- T0 lesion, unifocal or plurifocal, with or without micro-calcifications associated, measuring 15 mm maximum major axis on ultrasound.
- Clinical N0.
- Bra cup size greater than or equal to B.
- Markable and identifiable lesion in MRI.
- Indication of partial or total mastectomy in case of multifocal lesions or extensive calcification associated with axillary surgery.
- Breast assessment performed by a referent radiologist: Mammography, ultrasound, clinical examination.
- No contraindication to MRI.
You may not qualify if…
- Infiltrating lobular carcinoma and Pure ductal carcinoma in situ.
- Bilateral lesion.
- Non-detectable MRI lesions, within 10 mm of the skin, greater than 15 mm on ultrasound.
- Unifocal palpable tumor.
- Cup size bra equal to A.
- Cutaneous lesion on the breast to be treated by HIFU.
- Impossibility of ventral decubitus immobility, extended arm, during 1 hour.
- Pregnant or postpartum patient.
- Patient participating in another interventional clinical trial within 30 days of enrollment and during the trial.
Where it is running
- Institut Bergonie — Bordeaux, France (enrolling)
Full record on ClinicalTrials.gov
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