High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study
- Conditions
- Breast Cancer Female
- Interventions
- Device: High Instensity Focused Ultrasound
- Registration Number
- NCT03342625
- Lead Sponsor
- Institut Bergonié
- 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 Focused Ultrasound (HIFU) is a minimally invasive technique which decreases the risk of post-treatment complications and allows shorter hospitalization times. This technology is also remarkable for the absence of limitation related to the dose delivered, which makes it possible to repeat if necessary and the absence of ionizing radiation both for the treatment itself and for its guidance (MRI).
The main objective is to evaluate the efficacy of HIFU for the treatment of breast tumors, based on histological criteria.
Indication :
Histologically invasive ductal carcinoma, T0, with unifocal or plurifocal lesion, with or without associated microcalcifications, measuring 15 mm maximum on ultrasound and clinical N0.
Course of the study :
* Signature of consent,
* Clinical and radiological assessment at Baseline,
* Realization of the HIFU procedure under local anesthesia and sedation (J0),
* Total or partial mastectomy depending on the lesion (between D2 and D8),
* Consultation with surgeon (J30),
Number of patients :
15 patients will be included in this pilot study. If no success is observed, the study will be stopped and the technique considered inefficient. If there are one or more successes, an Independant Data Monitoring Committee (IDMC) will meet to propose an additional trial if necessary with the data from this trial.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High Intensity Focused Ultrasound High Instensity Focused Ultrasound High Intensity Focused Ultrasound for the treatment of breast tumors, guided by MRI
- Primary Outcome Measures
Name Time Method Efficacy of HIFU for the treatment of breast tumors, based on histological criteria Day 30 * 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 Outcome Measures
Name Time Method Immediate complications of focused ultrasound Day 30 Feasibility of non-invasive pre-surgical identification of the tumor area to be resected (palpation by the surgeon of the focused ultrasound ablation zone) Day 2, 8 Pain (visual analogue scale) experienced by patients during the sedation procedure, until surgery. Day 0, 2
Trial Locations
- Locations (1)
Institut Bergonie
🇫🇷Bordeaux, France