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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 : August 8, 2018
Sponsor:
Collaborator:
Ligue contre le cancer, France
Information provided by (Responsible Party):
Institut Bergonié

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

Condition or disease Intervention/treatment Phase
Breast Cancer Female Device: High Instensity Focused Ultrasound Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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 Name: HIFU




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. Immediate complications of focused ultrasound [ Time Frame: Day 30 ]
  3. Pain (visual analogue scale) experienced by patients during the sedation procedure, until surgery. [ Time Frame: Day 0, 2 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Jean PALUSSIERE, MD +33 5 56 33 37 50 j.palussiere@bordeaux.unicancer.fr
Contact: Simone MATHOULIN-PELISSIER, MD, PhD s.mathoulin@bordeaux.unicancer.fr

Locations
France
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Jean PALUSSIERE, MD    +33 5 56 33 37 50    j.palussiere@bordeaux.unicancer.fr   
Contact: Christine TUNON DE LARA, MD    +33 5 56 33 33 35    c.tunondelara@bordeaux.unicancer.fr   
Sponsors and Collaborators
Institut Bergonié
Ligue contre le cancer, France
Investigators
Study Chair: Jean PALUSSIERE, MD Institut Bergonié

Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT03342625     History of Changes
Other Study ID Numbers: IB 2015-01
ID-RCB number : 2017-A01490-53 ( Other Identifier: ANSM )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Bergonié:
High intensity focused ultrasound

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases