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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-03-31

Brief Summary

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The treatment consists of tumor ablation by Ablathermy Focused Ultrasound (USF), guided by MRI, performed under local anesthesia and sedation.

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Detailed Description

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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.

Conditions

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Breast Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ablathermy focused ultrasound

Group Type EXPERIMENTAL

ablathermy focused ultrasound

Intervention Type PROCEDURE

ablathermy focused ultrasound

Interventions

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ablathermy focused ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No