breast cancer malignant breast tumor
Conditions
Interventions
This study will be performed according to a treat-and-resect protocol. The
entire breast tumor including a 5 mm safety margin will be ablated with the
dedicated breast system. After 1-3 weeks, patie
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Women, aged 18 years and older. • Able to give informed consent herself. • World Health Organization (WHO) performance score
Exclusion criteria
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 any contrast agent, renal failure (GFR 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 and MammaPrint high risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the efficacy of MR-HIFU for ablation of breast tumors assessed by the amount of necrotic tumor tissue, which will be determined by MRI and by histopathologic examination after resection. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is safety, assessed by reporting adverse events and by NRS (numeric rating scale) after the MR-HIFU procedure. | — |
Countries
Netherlands
Outcome results
None listed