High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study

Breast Cancer Female Clinical Trial

— BRIFU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03342625
• Other study ID #: IB 2015-01
• Secondary ID: ID-RCB number :
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: January 2021

Study information

• Verified date: November 2019
• Source: Institut Bergonié
• Contact: Jean PALUSSIERE, MD
• Phone: +33 5 56 33 37 50
• Email: j.palussiere[@]bordeaux.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Device:
• High Instensity Focused Ultrasound
High Intensity Focused Ultrasound guided by MRI

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
Institut Bergonié	Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Immediate complications of focused ultrasound		Day 30
Secondary	Pain (visual analogue scale) experienced by patients during the sedation procedure, until surgery.		Day 0, 2