Efficacy of MR-HIFU Ablation of Breast Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MR-HIFU ablation 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). |
Device: Philips Sonalleve MR-HIFU Breast Tumor Therapy System
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) is a completely non-invasive treatment technique. HIFU uses focused ultrasound to achieve temperature rise in the targeted tissue. Real time monitoring of the treatment with MR-thermometry is used to ensure optimal safety.
|
Outcome Measures
Primary Outcome Measures
- Amount of ablated tissue at histopathological examination [2-3 weeks (after surgery is performed)]
The amount of ablated tissue and residual viable tumor tissue will be assessed in all tumor slices.
- Presence of non-perfused volumes on DCE-MRI [1 week after MR-HIFU ablation]
Efficacy will be assessed by the presence of non-perfused volumes on DCE-MRI. A pre-treatment MRI is used as comparison.
Secondary Outcome Measures
- Number of patients with adverse events [Approximately 2 to 3 weeks]
Adverse events will be documented. The (possible) relationship with MR-HIFU ablation will be asessed in all cases.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Utrecht | Utrecht | Netherlands | 3584 CX |
Sponsors and Collaborators
- UMC Utrecht
Investigators
- Principal Investigator: Manon NG Braat, MD, UMC Utrecht
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL46863.041.14