Status:
RECRUITING
High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study
Lead Sponsor:
Institut Bergonié
Collaborating Sponsors:
Ligue contre le cancer, France
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.
Detailed Description
Incidence of breast cancer increases with the lifetime of the population, and represents an important socio-economic issue. Diagnosis and treatment are major public health issues. High Instensity Focu...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- 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.
- Exclusion Criteria :
- 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.
Exclusion
Key Trial Info
Start Date :
June 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03342625
Start Date
June 7 2018
End Date
January 1 2027
Last Update
October 2 2025
Active Locations (1)
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1
Institut Bergonie
Bordeaux, France, 33076