Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy (USF)

September 10, 2025 updated by: Institut Bergonié
The treatment consists of tumor ablation by Ablathermy Focused Ultrasound (USF), guided by MRI, performed under local anesthesia and sedation.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The treatment consists of tumor ablation by USF, guided by MRI, performed under local anesthesia and sedation. Patients will be operated (mastectomy) from 48 hours after ablation.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33000
        • Institut Bergonie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Invasive Breast Carcinoma with histologically confirmed hormone receptor analysis, the grade of the tumor, the expression of Her-2.
  • Lesion classified T1-T2-T3 unifocal or multifocal with or without associated microcalcifications
  • Lesion recognizable and identifiable in MRI
  • Indication of mastectomy with or without axillary
  • Lesion located more than 10 mm from the skin, the nipple and pectoralis major
  • No cons-indication to MRI (pacemaker)
  • Women whose age is ≥ 18 years
  • If premenopausal patient: patient contraceptives
  • Patient has signed informed consent
  • Affiliation to a social security scheme

Exclusion Criteria:

  • Tumor-TD T4B classified or non-palpable lesion
  • If age <70 years: no indication of adjuvant chemotherapy and neoadjuvant
  • MRI lesions have not been identified, located within 10 mm of the skin and pectoral muscle, greater than 25 mm diameter
  • Inability to hold still in the prone position, arms extended, for 30 minutes
  • Contraindication to MRI
  • Patient deprived of liberty and major subject of a measure of legal protection or unable to consent
  • Patient participating in another interventional clinical trial within 30 days prior to baseline and during the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ablathermy focused ultrasound
Procedure: ablathermy focused ultrasound
ablathermy focused ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of ablathermy
Time Frame: 2 years
Effectiveness of ablathermy focused ultrasound breast tumors will be assessed based on histological criteria : the intervention will be considered effective for a participant if there is a destruction of the tumor mass by coagulation necrosis
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Assessment of apoptotic phenomena in the margins of lesions treated
Time Frame: 2 years
  • Assessment of apoptotic phenomena in the margins of lesions treated
  • Know the immediate complications focused ultrasound
  • Assess the pain experienced by patients during the procedure performed under sedation.
  • Check the real-time processing by mapping temperature measured by MRI and correlate these mappings to the histological findings
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Investigators

  • Study Chair: PALUSSIERE Jean, MD, Institut Bergonie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

November 6, 2012

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimated)

April 10, 2013

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2009-58

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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