Clinical trial · Interventional
Efficacy of MR-HIFU Ablation of Breast Cancer
Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
NCT02407613CI-TRIAL-00077356withdrawnN/AClinicalTrials.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): Patient recruitment was not feasible.
Summary
Brief summary (as posted)
This study evaluates the efficacy of MR-HIFU ablation of breast cancer. Ten patients with early-stage breast cancer with a maximum diameter of 3 cm will undergo MR-HIFU ablation, followed by MRI and surgical resection to evaluate treatment effect. The main purpose of the study is to demonstrate the feasibility of total tumor ablation with MR-HIFU. The secondary objective is safety assessment.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Philips Sonalleve MR-HIFU Breast Tumor Therapy System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MR-HIFU ablation
- description
- Ten patients undergo MR-HIFU ablation with the Sonalleve MR-HIFU Breast Tumor Therapy System (Profound Medical). According to a treat-and-resect protocol, these patients also undergo standard therapy consisting of breast cancer surgery 1 to 2 weeks after MR-HIFU treatment (+/- radiotherapy).
- interventionNames
- Device: Philips Sonalleve MR-HIFU Breast Tumor Therapy System
Primary outcomes (2)
- measure
- Amount of ablated tissue at histopathological examination
- timeFrame
- 2-3 weeks (after surgery is performed)
- description
- The amount of ablated tissue and residual viable tumor tissue will be assessed in all tumor slices.
- measure
- Presence of non-perfused volumes on DCE-MRI
- timeFrame
- 1 week after MR-HIFU ablation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women, aged 18 years and older. * Able to give informed consent herself. * World Health Organization (WHO) performance score ≤ 2. * Biopsy proven cT1-2 N0-2 MX invasive breast cancer with a size of ≤ 3.0 cm. * Histological type of tumor: invasive ductal carcinoma (IDC), not otherwise specified (NOS) or no special type (NST). * The target breast fits in the cup of the dedicated MR-HIFU breast system. * Patient weight is limited to ≤ 90 kg, because of restrictions to the HIFU table top. Additional inclusion criteria based on DCE-MRI findings: * The distance of the tumor, including a 5 mm margin around the tumor, from the skin, nipple and pectoral wall is at least 1.0 cm measured on MRI. * The tumor is located within the reach of the HIFU beam produced by the transducers in the HIFU breast system. Exclusion Criteria: * Prior treatment with: neo-adjuvant systemic therapy in the past 3 months or radiotherapy or thermal therapy or surgery of any kind in the targeted breast. * Contraindications to MR imaging according to the hospital guidelines (e.g. pacemaker in situ, severe claustrophobia, big metal implants, body size incompatible with MR bore). * Contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, kidney disease (e.g. nephrogenic systemic fibrosis, nephrogenic fibrosing dermopathy) and/or renal failure (GFR \< 30 ml/min/1,73m2). * Contra-indications for procedural sedation analgesia with Propofol and Esketamine or Propofol and Remifentanil. * Extensive intraductal components in the lesion determined by biopsy. * Scar tissue or surgical clips in the HIFU beam path. * Inability to lie in prone position. * Pregnancy or lactation. * Communication barrier with patient. The following groups of patients will be excluded because the risk of adjuvant over- or undertreatment due to performing the Bloom and Richardson (B\&R) grading on the tumor biopsy is considered to high: * N0, Her2neu negative, \<35 years, ≤1cm (T1a/b) with B\&R grade 1 or 2 on biopsy. * N0 Her2neu negative, ER/PR negative (triple negative), 35-70yr, 1.1-2cm (T1c) with B\&R grade 1 or 2 on biopsy. * N0, Her2neu negative, ER/PR positive \> 50%, ductal carcinoma, 60-70yr, 1.1-2cm (T1c), with B\&R grade 3 on biopsy and if the MammaPrint is not reimbursed by health insurance also for grade 1 on biopsy. * N0, Her2neu negative, ER/PR positive, ductal carcinoma, 35-60yr, 1.1-2cm (T1c) with B\&R grade 1 on biopsy. * N0, Her2neu negative, ER/PR positive, but ≤50%, ductal carcinoma, 60-70yr, 1.1-2cm (T1c) with B\&R grade 1. The following group of patients will be excluded based on the results of the MammaPrint: • Only if the MammaPrint is reimbursed by health insurance: N0, Her2neu negative, ER/PR positive, \> 50% ductal carcinoma, 60-70yr, 1.1-2cm (T1c), with B\&R grade 1 and MammaPrint high risk.
References
Publications (0)
Data not yet available
No reference posted for this study.