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

Not Applicable

Terminated

• Conditions: Breast Tumor
• Interventions: Procedure: ablathermy focused ultrasound

• Registration Number: NCT01827969
• Lead Sponsor: Institut Bergonié

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.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2012-11-06
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-09
• Last Update Submitted: 2013-04-09
• Study First Posted: 2013-04-10
• Last Update Posted: 2013-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ablathermy focused ultrasound	ablathermy focused ultrasound	ablathermy focused ultrasound

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of ablathermy	2 years	Evaluate the effectiveness of ablathermy focused ultrasound breast tumors on histological criteria in terms of destruction of the tumor mass by coagulation necrosis

Secondary Outcome Measures

Name	Time	Method
- Assessment of apoptotic phenomena in the margins of lesions treated	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

Trial Locations

Locations (1)

Institut Bergonié; 🇫🇷 Bordeaux, Aquitaine, France