Imaging quality and potential clinical relevance of breast computed tomography in-vivo: a single-centre, prospective study
Early Phase 1
- Conditions
- C50Malignant neoplasm of breast
- Registration Number
- DRKS00015475
- Lead Sponsor
- niversitätsspital Zürich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 330
Inclusion Criteria
Inclusion criteria
- Phase 1 und 2: Patients >18 years with provided informed consent:
• Patients with BI-RADS 5/6 lesions
• Mastectomy or segmentectomy +/- radiotherapy planned
Inclusion criteria
- Phase 3: Patients >18 years with provided informed consent:
• Patients registered for diagnostic or screening mammography.
Exclusion Criteria
Pregnancy, breast-feeding, re-staging after neoadjuvant chemotherapy. In phase 1 clip after biopsy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 330 patients will be included to obtain the sensitivity and specificity of the breast CT compared to conventional mammography.<br><br>The mammograms and the breast CT Images will be evaluated seperately by two board-certified radiologists and rated according the BI-RADS criteria.<br>
- Secondary Outcome Measures
Name Time Method