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Search / Trial NCT06773598

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

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Jan 9, 2025

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Radiomics Mp Mri

ClinConnect Summary

This clinical trial is looking at a new tool that uses advanced imaging technology, called Multiparametric Magnetic Resonance Imaging (MRI), to help predict the presence of prostate cancer. The researchers want to see how well this machine learning model can accurately identify whether someone has prostate cancer by checking its accuracy in two main areas: how well it can correctly identify people who do not have the disease (specificity) and how well it can identify those who do have it (sensitivity).

To participate in this study, you need to be at least 18 years old and provide informed consent. You should also have been diagnosed with certain lesions during an MRI and have a recommendation for a specific type of biopsy. However, if you've had previous prostate surgery or hormone therapy, or if your MRI images are not clear due to other medical devices or movements, you may not be eligible. Participants can expect to undergo the necessary imaging and biopsy procedures at the IRCCS Azienda Ospedaliero-Universitaria in Bologna, where the study is taking place. This research aims to improve how doctors predict and diagnose prostate cancer, ultimately leading to better patient care.

Gender

ALL

Eligibility criteria

  • 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.)

About Irccs Azienda Ospedaliero Universitaria Di Bologna

IRCCS Azienda Ospedaliero-Universitaria di Bologna is a prestigious research and healthcare institution in Italy, renowned for its commitment to advancing medical science and patient care through innovative clinical research. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it integrates clinical practice with scientific research, facilitating the translation of laboratory findings into effective treatment strategies. The institution fosters a multidisciplinary approach, collaborating with various experts to conduct high-quality clinical trials aimed at improving health outcomes across a wide range of medical fields. With a strong emphasis on ethical standards and patient welfare, IRCCS Azienda Ospedaliero-Universitaria di Bologna plays a vital role in shaping the future of medicine through rigorous scientific inquiry and patient-centered care.

Locations

Bologna, , Italy

Patients applied

0 patients applied

Trial Officials

Caterina Gaudiano, MD

Principal Investigator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported