Contrast-enhanced MR imaging of the breast at 7T and 3T in the same patients.
Completed
- Conditions
- breast cancerbreast neoplasm10006291
- Registration Number
- NL-OMON40016
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
18 years or older
Female patients
A BI-RADS 4 or higher classification for a lesion detected at mammography and/or ultrasound
Exclusion Criteria
Surgery or radiotherapy to the ipsilateral breast up to one year before inclusion
Prior treatment with chemotherapy
Karnofsky score <= 70
Pregnant or lactating women
Contra-indications to MRI scanning according to our hospitals 3T or 7T MRI screening-guideline
Contra-indications to injection of gadolinium-based contrast agent, including known
prior allergic reaction to any contrast-agent, and renal failure, defined by GFR <30mL/min/1.73m2
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the diagnostic performance of 7T CE Breast MRI in comparison with the<br /><br>clinical standard of 3T MRI (by using the BI-RADS MRI lexicon) and<br /><br>histopathology, on a intra-individual basis. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess the diagnostic performance of 7T versus 3T on a per lesion basis.<br /><br>- To assess the correlation of 7T MRI lesion size to 3T MRI lesion size and to<br /><br>lesion size determined on histopathology after surgery.</p><br>