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

Study Overview
=================
Brief Summary
-----------------
The treatment consists of tumor ablation by Ablathermy Focused Ultrasound (USF), guided by MRI, performed under local anesthesia and sedation.

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.

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

Conditions
-----------------
Breast Tumor

Intervention / Treatment
-----------------
* Procedure: ablathermy focused ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ablathermy focused ultrasound<br>ablathermy focused ultrasound | Procedure: ablathermy focused ultrasound<br>* ablathermy focused ultrasound<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of ablathermy | Evaluate the effectiveness of ablathermy focused ultrasound breast tumors on histological criteria in terms of 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Women, breast tumor, planned mastectomy