High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High Instensity Focused Ultrasound.
- Who it may be relevant to
- Registry conditions: Breast Cancer Female. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study (Breast Resection By HIFU)
Overview
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.
Interventions
- Device High Instensity Focused Ultrasound
High Intensity Focused Ultrasound guided by MRI
Primary outcome measures
- Efficacy of HIFU for the treatment of breast tumors, based on histological criteria [Time frame: Day 30]
Secondary outcome measures (3)
- Feasibility of non-invasive pre-surgical identification of the tumor area to be resected (palpation by the surgeon of the focused ultrasound ablation zone) [Time frame: Day 2, 8]
- Immediate complications of focused ultrasound [Time frame: Day 30]
- Pain (visual analogue scale) experienced by patients during the sedation procedure, until surgery. [Time frame: Day 0, 2]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Institut Bergonie — Bordeaux
Identifiers
NCT: NCT03342625 · IB 2015-01 · ID-RCB number : 2017-A01490-53