High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study (BRIFU)
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|ClinicalTrials.gov Identifier: NCT03342625|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Female||Device: High Instensity Focused Ultrasound||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study (Breast Resection By HIFU)|
|Actual Study Start Date :||June 7, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: High Intensity Focused Ultrasound
High Intensity Focused Ultrasound for the treatment of breast tumors, guided by MRI
Device: High Instensity Focused Ultrasound
High Intensity Focused Ultrasound guided by MRI
Other Name: HIFU
- Efficacy of HIFU for the treatment of breast tumors, based on histological criteria [ Time Frame: 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342625
|Contact: Jean PALUSSIERE, MD||+33 5 56 33 37 email@example.com|
|Contact: Simone MATHOULIN-PELISSIER, MD, PhDfirstname.lastname@example.org|
|Study Chair:||Jean PALUSSIERE, MD||Institut Bergonié|