Clinical trial · Interventional
Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy
NCT01827969CI-TRIAL-00095208USFwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The treatment consists of tumor ablation by Ablathermy Focused Ultrasound (USF), guided by MRI, performed under local anesthesia and sedation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Tumor | Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ablathermy focused ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ablathermy focused ultrasound
- description
- ablathermy focused ultrasound
- interventionNames
- Procedure: ablathermy focused ultrasound
Primary outcomes (1)
- measure
- Effectiveness of ablathermy
- timeFrame
- 2 years
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.