breast cancer malignant breast neoplasm
Conditions
Interventions
HIFU uses focused ultrasound waves to heat and thermally ablate tissue. In this
study only a part of the breast tumor will be ablated. The MRI system
identifies the ultrasound path and monitors heat
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Female aged 18 years and over Able to give informed consent herself World Health Organization performance score = 1.0 cm) invasive breast cancer, confirmed by histopathology. Size of the tumor is determined on mammography or ultrasound
Exclusion criteria
Exclusion criteria: Patients treated with neo-adjuvant systemic therapy Contra-indications for MRI scanning according to the hospital guidelines Contra-indications to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast-agent, and renal failure, defined by GFR
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| A secondary endpoint of this study is safety of MR-HIFU in breast cancer patients using a dedicated MR-HIFU breast system. To determine the safety, the following endpoints will be recorded: any minor complications or adverse events that result from HIFU treatment. Pain during HIFU treatment will be recorded according to the Numerical Representative Scale (NRS) | — |
Primary
| Measure | Time frame |
|---|---|
| The main endpoint of this feasibility study is treatment accuracy of MR-HIFU in breast cancer patients using a dedicated MR-HIFU breast system. Accuracy of treatment will be assessed by comparing the ablated volumes by HIFU to three parameters related to the success of HIFU treatment. These parameters are 1) MR thermal dose predicted treatment volumes 2) treatment planning volumes and 3) histopathology. | — |
Countries
Netherlands
Outcome results
None listed