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
The dedicated MR-HIFU unit has been shown to be safe and feasible to ablate breast tissue. The planned study should address the possibility to completely ablate breast cancer with the dedicated breast MR-HIFU unit. The result of the MR-HIFU therapy should be monitored by imaging (contrast enhanced MRI) as well as with histopathological correlation after surgery. The patient population would consist of female patients with proven breast cancer scheduled for surgical lumpectomy or mastectomy. The idea is to evaluate a minimal invasive method to treat breast cancer as a potential alternative to surgical resection in the future
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.
Kantonsspital Winterthur
Winterthur, Switzerland
Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method)
Quantitative assessment: Correlation between MRI and histopathology results (volume of necrosis)
Time frame: Day 14
Assessment of Treatment Efficacy
Effective treatment is defined as complete necrosis (100%) of targeted tumor including safety margin (\>1mm) (histopathological analysis). Safety margin: measurement of smallest margin on histology and measurement of smallest margin on MRI. Parameter: Percentage of necrosis including safety margin
Time frame: Day 14
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