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

NCT01827969 | Withdrawn DMC

• 1 other identifier: IB2009-58
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Tumor

Keywords

Women; breast tumor; planned mastectomy

Outcome Measures

Primary Outcomes (1)

• Effectiveness of ablathermy

  Effectiveness of ablathermy focused ultrasound breast tumors will be assessed based on histological criteria : the intervention will be considered effective for a participant if there is a destruction of the tumor mass by coagulation necrosis

  2 years

Study Arms (1)

ablathermy focused ultrasound

EXPERIMENTAL

ablathermy focused ultrasound

Procedure: ablathermy focused ultrasound

Interventions

ablathermy focused ultrasound PROCEDURE

ablathermy focused ultrasound

ablathermy focused ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonié

Bordeaux, Aquitaine, 33000, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• PALUSSIERE Jean, MD

  Institut Bergonié

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: April 10, 2013
• Study Start: December 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)