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RecruitingNot ApplicableNCT03342625

High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study

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

Sponsor

Institut Bergonié

Enrollment

15 participants

Start Date

Jun 7, 2018

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Female

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

  • 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.

Exclusion Criteria9

  • 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.

Interventions

DEVICEHigh Instensity Focused Ultrasound

High Intensity Focused Ultrasound guided by MRI

Locations(1)

Institut Bergonie

Bordeaux, France

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NCT03342625

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