High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study

NCT03342625 | Recruiting DMC

• 2 other identifiers: IB 2015-01ID-RCB number : 2017-A01490-53
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.

Conditions

Breast Cancer Female

Keywords

High intensity focused ultrasound

Outcome Measures

Primary Outcomes (1)

• Efficacy of HIFU for the treatment of breast tumors, based on histological criteria

  * 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.

  Day 30

Secondary Outcomes (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)

  Day 2, 8

• Immediate complications of focused ultrasound

  Day 30

• Pain (visual analogue scale) experienced by patients during the sedation procedure, until surgery.

  Day 0, 2

Study Arms (1)

High Intensity Focused Ultrasound

EXPERIMENTAL

High Intensity Focused Ultrasound for the treatment of breast tumors, guided by MRI

Device: High Instensity Focused Ultrasound

Interventions

High Instensity Focused Ultrasound DEVICE

High Intensity Focused Ultrasound guided by MRI

Also known as: HIFU

High Intensity Focused Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Bergonié: lead
• Ligue contre le cancer, France: collaborator

Study Sites (1)

Institut Bergonie

Bordeaux, 33076, France

RECRUITING

Study Officials

• Jean PALUSSIERE, MD

  Institut Bergonié

  STUDY CHAIR

Central Study Contacts

Jean PALUSSIERE, MD

CONTACT

+33 5 56 33 37 50; j.palussiere@bordeaux.unicancer.fr

Simone MATHOULIN-PELISSIER, MD, PhD

CONTACT

s.mathoulin@bordeaux.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: June 7, 2018
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-10

Locations

FR (1)