Validation of a Machine Learning Model Based on MR for the Prediction of Prostate Cancer
Recruiting · NCT06773598 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
View the official record on ClinicalTrials.gov →What this trial is about
The goal of this observational study is to validate a clinically significant predictive machine learning model based on the processing of images RMmp (Multiparametric Magnetic Resonance Imaging). To be validated the model should be evaluated on: * Specificity (SP): is the probability of a negative test result, conditioned on the individual truly being negative * Sensitivity (SN): is the probability of a positive test result, conditioned on the individual truly being positive
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Participants aged 18 at the time of examination
- Obtaining informed consent
- Presence of one or more lesions classified as PI-RADSv2.1 ≥ 1 at a prostate RMmp at the IRCCS Azienda Ospedaliero-Universitaria in Bologna
- Indication for TRUS biopsy by fusion technique integrated with systematic biopsy at the IRCCS Azienda Ospedaliero-Universitaria in Bologna
Exclusion criteria
- Previous prostate surgery or hormone therapy
- Technically sub-optimal investigations for the presence of artifacts (hip prosthesis, movement of the endorectal probe, etc.)
Where it is running
1 location listed.
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Bologna, Italy