NCT06774781

Assessment of ADC Values and Radiomics Characteristics With a MRI of the Prostate to Identify Tumor Lesions

Assessment of the Distribution of ADC Values and Radiometric Characteristics of Suspect Areas With a Multiparametric MRI of the Prostate to Identify Clinically Significant Neoplastic Lesions

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to assess the chance to predict prostate cancer with the analysis of specific values found in images obtained from RMmp (multiparametric magnetic resonance imaging) of patients who went through the procedure at IRCCS Azienda Ospedaliero-Universitaria hospital in the city of Bologna from September 2015 to March 2021. The main question it aims to answer is: \- does the analysis of ADC values and radiomics values found in the RMmp images help with the detection of prostate cancer?

Detailed description

The radiologist involved in this observational study will enroll the participants, collect their informed consent and radiological data. The urologist will collect the clinical data while the Anatomo-pathologist will take care of the hystological data. The ADC values of the suspected lesions and healthy parenchyma will be extracted from the MR exams. For the evaluation of radiometric characteristics, images will first be de-identified, the downloaded and processed by the hospital's medical physicists. The engineers at the University of Bologna, led by medical investigators, will extract the radiomic characteristics All data will be anonymised and collected in a database shared between the collaborating operational units.

Conditions

• Prostate Cancer (Adenocarcinoma)

Timeline

• Start date: 2021-10-23
• Primary completion: 2024-12-31
• Completion: 2025-01-31
• First posted: 2025-01-14
• Last updated: 2025-01-14

Locations

1 site across 1 country: Italy