Clinical trial · Interventional
High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study
High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study (Breast Resection By HIFU)
NCT03342625CI-TRIAL-00096189BRIFUrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Instensity Focused Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High Intensity Focused Ultrasound
- description
- High Intensity Focused Ultrasound for the treatment of breast tumors, guided by MRI
- interventionNames
- Device: High Instensity Focused Ultrasound
Primary outcomes (1)
- measure
- Efficacy of HIFU for the treatment of breast tumors, based on histological criteria
- timeFrame
- Day 30
- description
- * Complete success: absence of viable invasive tumor cells on histological analysis. * Incomplete success: Partial tumor destruction of the invasive contingent, unhealthy margins due to underestimation of tumor volume before treatment or imperfect targeting of focused ultrasound. Incomplete successes will be considered as failures. The persistence of an in situ quota alone will be considered as success. * Failure: presence of viable invasive tumor cells in the treated area.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.