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

Breast Tumor Clinical Trial

— USF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01827969
• Other study ID #: IB2009-58
• Status: Terminated
• Phase: N/A
• First received: November 6, 2012
• Last updated: April 9, 2013
• Start date: December 2009
• Est. completion date: March 2011

Study information

• Verified date: April 2013
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Tumor

Intervention

Procedure:
• ablathermy focused ultrasound
ablathermy focused ultrasound

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux	Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	- 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	No

External Links

•   Registre des essais cliniques de l'INCa
•   Site internet du promoteur, l'Institut Bergonié