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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01827969
• Date of registration: 06/11/2012
• Prospective Registration: No
• Primary sponsor: Institut Bergonié
• Public title: Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy USF
• Scientific title: Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy
• Date of first enrolment: December 2009
• Target sample size: 1
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01827969
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: PALUSSIERE Jean, MD
• Affiliation: Institut Bergonié

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Tumor

Intervention(s)

Procedure: ablathermy focused ultrasound

Primary Outcome(s)

Evaluate the effectiveness of ablathermy [Time Frame: 2 years]

Secondary Outcome(s)

- Assessment of apoptotic phenomena in the margins of lesions treated [Time Frame: 2 years]

Secondary ID(s)

IB2009-58

Source(s) of Monetary Support

Please refer to primary and secondary sponsors