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Taking people in ItalyNo phase

Checking a Computer Model That Reads Prostate MRI Scans for Cancer

Checks a computer model reading prostate MRI scans for cancer in adults.

Plain-language title generated from the registry record
Registry title: Validation of a Machine Learning Model Based on MR for the Prediction of Prostate Cancer

Key facts

Where
Bologna, ItalySee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a prostate MRI showing at least one lesion and who need a prostate biopsy at one hospital in Bologna.

Age
18 years or older
Sex
All sexes can join.
Disease stage
One or more prostate lesions scored PI-RADSv2.1 ≥ 1 on a multiparametric prostate MRI.
Earlier treatment
People who had earlier prostate surgery or hormone therapy cannot join.

Main reasons for not taking part

  • Earlier prostate surgery or hormone therapy
  • MRI images of poor quality because of artifacts, such as a hip prosthesis or movement of the endorectal probe

Read by machine on 12 November 2026.

Where in Italy

  • IRCCS Azienda Ospedaliero-Universitaria di BolognaBologna, ItalyContact: Caterina Gaudiano, MDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Trial code
NCT06773598
Record updated
14 January 2025
Original description
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:Read full original descriptionShow less

Validation of a Machine Learning Model Based on Multiparametric MR for the Prediction of Clinically Significant Prostate Cancer

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

Inclusion: 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: Previous prostate surgery or hormone therapy; Technically sub-optimal investigations for the presence of artifacts (hip prosthesis, movement of the endorectal probe, etc.).

ClinicalTrials.gov NCT06773598