Microstructure modelling using enhanced diffusion-weighted magnetic resonance imaging for non-invasive prostate cancer diagnostics - a feasibility study
Recruiting
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00033122
- Lead Sponsor
- Virdx Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 75
Inclusion Criteria
patients are scheduled for an mpMRI examination due to suspected prostate carcinoma
Exclusion Criteria
- patients have a contraindication for an MRI scan AND
- patients have had previous radiotherapy of the prostate, hormone therapy, previous TUR-P or other prostate surgery AND
- patients lack willingness, ability and capacity to consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity, specificity and receiver operating characteristic (ROC) curve of the different biophysical models for the diagnosis of clinically significant prostate cancer
- Secondary Outcome Measures
Name Time Method Comparison with PI-RADS classification and existing biopsy results