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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01827969

Acronym

USF

Enrollment

Registered

2013-04-10

Start date

2009-12-31

Completion date

2011-03-31

Last updated

2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Tumor

Keywords

Women, breast tumor, planned mastectomy

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.

Interventions

PROCEDUREablathermy focused ultrasound

ablathermy focused ultrasound

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Effectiveness of ablathermy	2 years	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026