Status:
WITHDRAWN
Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy
Lead Sponsor:
Institut Bergonié
Conditions:
Breast Tumor
Eligibility:
FEMALE
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01827969
Start Date
December 1 2009
End Date
March 1 2011
Last Update
September 16 2025
Active Locations (1)
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1
Institut Bergonié
Bordeaux, Aquitaine, France, 33000