Feasibility of ultra high field 7.0 Tesla MRIfor the detection of breast cancer.
Completed
- Conditions
- Breast tumorBreast neoplasm
- Registration Number
- NL-OMON20303
- Lead Sponsor
- niversity Medical Center Utrecht (UMCU)Visiting address-----------------------Heidelberglaan 1003584 CX UtrechtThe NetherlandsPostal address---------------------Room E01.132PO Box 855003508 GA UtrechtThe NetherlandsPhone: +31 (0)88 75 555 55
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the 7T detection rate of stage T1 breast cancer lesions in a cohort of women with BI-RADS 4c of higher lesion at mammography, ultrasound and/or lower field strength MRI.
- Secondary Outcome Measures
Name Time Method 1. To assess the morphology of breast cancer at 7T as described according to the MRI BI-RADS lexicon;<br /><br>2. To assess the kinetics of lesion enhancement at 7T;<br /><br>3. To assess the correlation of 7T MRI lesion size and lesion size as determined by final pathological analysis. <br>