Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT03342625

High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study

Led by Institut Bergonié · Updated on 2025-10-02

15

Participants Needed

1

Research Sites

447 weeks

Total Duration

On this page

Sponsors

I

Institut Bergonié

Lead Sponsor

L

Ligue contre le cancer, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically proven invasive ductal carcinoma with hormone receptor, tumor grade, and Her-2 analysis
  • Lesions measuring 15 mm or less on ultrasound, unifocal or multifocal, with or without microcalcifications
  • Clinical stage N0 breast cancer
  • Bra cup size B or larger
  • Lesion identifiable and markable on MRI
  • Indication for partial or total mastectomy if multifocal or extensive calcifications with axillary surgery
  • Breast assessed by mammography, ultrasound, and clinical exam by a radiologist
  • No contraindications to MRI
Not Eligible

You will not qualify if you...

  • Infiltrating lobular carcinoma or pure ductal carcinoma in situ
  • Bilateral breast lesions
  • Lesions not detectable by MRI, within 10 mm of skin, or larger than 15 mm on ultrasound
  • Unifocal palpable tumor
  • Bra cup size A
  • Skin lesions on breast planned for HIFU treatment
  • Unable to maintain required position during treatment for 1 hour
  • Pregnant or postpartum patients
  • Participation in another interventional clinical trial within 30 days before enrollment or during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institut Bergonie

Bordeaux, France, 33076

Actively Recruiting

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Research Team

J

Jean PALUSSIERE, MD

CONTACT

S

Simone MATHOULIN-PELISSIER, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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