C61
Conditions
Interventions
Group 1: Inclusion of patients with an indication for MRI/ultrasound fusion biopsy (MRI/US FB) of the prostate in the period 01/01/2022 to 31/08/2022
Sponsors
Vivantes Klinikum Am Urban
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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) 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
| Measure | Time frame |
|---|---|
| - correspondence of the localisation of index lesions in the mpMRI with the ROIs in the AI software - determination of the rate of additionally detected prostate cancer in ROIs of the AI software without detection in the radiological reporting - comparison of the prostate volumes determined by ultrasound, MRI and AI software, as well as the PSA densities based on the prostate volume | — |
Countries
Germany
Contacts
Public ContactKarsten Günzel
Vivantes Klinikum Am Urban
Outcome results
None listed