NCT03342625

High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study

High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study (Breast Resection By HIFU)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
DEVICE	High Instensity Focused Ultrasound	High Intensity Focused Ultrasound guided by MRI

Timeline

• Start date: 2018-06-07
• Primary completion: 2026-06-01
• Completion: 2027-01-01
• First posted: 2017-11-17
• Last updated: 2025-10-02

Locations

1 site across 1 country: France