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

Institut Bergonié

Status

Withdrawn

Conditions

Breast Tumor

Treatments

Procedure: ablathermy focused ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT01827969

IB2009-58

Details and patient eligibility

About

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

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.