Prospective evaluation of an artificial intelligence (AI)-assisted, software-based (Quantib®Prostate) reporting of multiparametric magnetic resonance imaging (MRI) in the context of MRI/ultrasound fusion biopsies of the prostate
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00033322
- Lead Sponsor
- Vivantes Klinikum Am Urban
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 262
Inclusion Criteria
patients with an mpMRI of the prostate (T2, DWI and, if applicable, DCE sequences) who are suitable for evaluation with the Quantib®Prostate AI software and who subsequently undergo an MRI/US fusion biopsy of the prostate with needle tracking at the urology clinic of Vivantes Klinikum Am Urban.
Exclusion Criteria
- inadequate image quality of the mpMRI
- missing mpMRI before biopsy
- missing mpMRI sequences for analysis by the AI software
- premature termination of the prostate biopsy or insufficient histological material for subsequent analyses
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Calculation of the PCa detection rate by an MRI/ultrasound fusion biopsy of the prostate in suspicious lesions (ROI) of the mpMRI detected by the AI software (Quantib®Prostate)<br><br>Calculation of the PCa detection rate by an MRI/ultrasound fusion biopsy of the prostate in suspicious lesions of the mpMRI described by the radiological PI-RADS reporting (index lesion)
- Secondary Outcome Measures
Name Time Method - correspondence of the localisation of index lesions in the mpMRI with the ROIs in the AI software<br>- determination of the rate of additionally detected prostate cancer in ROIs of the AI software without detection in the radiological reporting<br>- comparison of the prostate volumes determined by ultrasound, MRI and AI software, as well as the PSA densities based on the prostate volume