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

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

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Female
• Intervention / Treatment: Device: High Instensity Focused Ultrasound

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean PALUSSIERE, MD; Phone Number: +33 5 56 33 37 50; Email: j.palussiere@bordeaux.unicancer.fr

Study Locations

• France
  • Bordeaux, France, 33076
    • Recruiting
    • Institut Bergonie
    • Contact: Jean PALUSSIERE, MD; Phone Number: +33 5 56 33 37 50; Email: j.palussiere@bordeaux.unicancer.fr
    • Contact: Christine TUNON DE LARA, MD; Phone Number: +33 5 56 33 33 35; Email: c.tunondelara@bordeaux.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria :

1. Histologically proven infiltrating ductal carcinoma with the analysis of hormone receptors, tumor grade, Her-2 expression.
2. T0 lesion, unifocal or plurifocal, with or without micro-calcifications associated, measuring 15 mm maximum major axis on ultrasound.
3. Clinical N0.
4. Bra cup size greater than or equal to B.
5. Markable and identifiable lesion in MRI.
6. Indication of partial or total mastectomy in case of multifocal lesions or extensive calcification associated with axillary surgery.
7. Breast assessment performed by a referent radiologist: Mammography, ultrasound, clinical examination.
8. No contraindication to MRI.

Exclusion Criteria :

1. Infiltrating lobular carcinoma and Pure ductal carcinoma in situ.
2. Bilateral lesion.
3. Non-detectable MRI lesions, within 10 mm of the skin, greater than 15 mm on ultrasound.
4. Unifocal palpable tumor.
5. Cup size bra equal to A.
6. Cutaneous lesion on the breast to be treated by HIFU.
7. Impossibility of ventral decubitus immobility, extended arm, during 1 hour.
8. Pregnant or postpartum patient.
9. Patient participating in another interventional clinical trial within 30 days of enrollment and during the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: HIFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Collaborators: Ligue contre le cancer, France
• Investigators: Study Chair: Jean PALUSSIERE, MD, Institut Bergonie

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: High intensity focused ultrasound
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IB 2015-01; ID-RCB number : 2017-A01490-53 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No