Contrast-enhanced MR imaging of the breast at 7T and 3T in the same patients.
- Conditions
- breast cancer, breast neoplasia
- Registration Number
- NL-OMON27773
- Lead Sponsor
- niversity Medical Center Utrecht (UMCU)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. 18 years or older;
2. Female patients;
Exclusion Criteria
1. Any prior surgery or radiotherapy to the ipsilateral breast;
2. Karnofsky score <= 70;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary aim is to assess the diagnostic performance of 7T CE breast MRI. This is done by comparing the final 7T BI-RADS-MRI classification to the final 3T BI-RADS-MRI classification and to histopathology obtained after biopsy and surgery.
- Secondary Outcome Measures
Name Time Method 1. To establish the per-lesion diagnostic accuracy of 7T;<br /><br>2. Comparison of lesion size as determined at 7T, 3T and final pathology.