Clinical trial · Interventional
Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer: Correlation Between MRI and Histology. Single-Center, Single-Arm, Non-Randomized Trial
NCT03560102CI-TRIAL-00054623terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): recruitment difficulties
Summary
Brief summary (as posted)
The purpose of the study is to evaluate the efficacy of a dedicated Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) unit in ablating breast cancer by comparing MR imaging and pathologic specimen after resection. Single-center, single-arm, non-randomized trial
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 Cancer, Invasive Ductal | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Philips Sonalleve® MR-HIFU Breast Therapy System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MR-HIFU treatment
- description
- Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\& resect model
- interventionNames
- Device: Philips Sonalleve® MR-HIFU Breast Therapy System
Primary outcomes (1)
- measure
- Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method)
- timeFrame
- Day 14
- description
- Quantitative assessment: Correlation between MRI and histopathology results (volume of necrosis)
Secondary outcomes (1)
- measure
- Assessment of Treatment Efficacy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed Consent as documented by signature * World Health Organization (WHO) performance status≤ 2 * Body weight ≤ 80 kg * Biopsy proven invasive breast cancer with a size of ≤3.0cm (TNM classification: cT1-2 N0-2 MX ). * Histological type of tumor: invasive ductal carcinoma (IDC) * Patient is scheduled for surgical resection of tumor at study site * Tumor location within the reach of the HIFU transducers with the patient in prone position; distance from skin and pectoral muscle to the tumor ≥ 1.0 cm. * Target breast fits in the cup of the dedicated MR-HIFU breast system Exclusion Criteria: * neoadjuvant systemic therapy * prior radiotherapy in target breast * contraindications for MRI * contraindication for application of gadolinium-based contrast agent * contraindication for procedural sedation analgesia * macro-calcifications in or around the targeted tumor * scar tissue or surgical clips in the direct path of the ultrasound beams * Women who are pregnant or breast feeding, * Intention to become pregnant during the course of the study, * Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. * Known or suspected non-compliance, drug or alcohol abuse, * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * Participation in another study with investigational drug/device within the 30 days preceding and during the present study, * Previous enrolment into the current study
References
Publications (0)
Data not yet available
No reference posted for this study.