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

NCT ID: NCT06774781

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-23
• Study Completion Date: 2025-01-31

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Presence of one or more lesions classified as PI-RADSv2.1 ≥ 3 at a prostate RMmp at the IRCCS Azienda Ospedaliero-Universitaria in Bologna
• Indication for eco-guided targeted biopsy by fusion technique integrated with systematic biopsy
• Indication for radical prostatectomy
• Participants aged 18 at the time of examination
• Obtaining informed consent.

Exclusion Criteria

• Impossibility of performing MRI (claustrophobic or obese participants etc.) or contraindications to the execution of MRI
• Technically sub-optimal investigations for the presence of artifacts (hip prosthesis, movement of the endorectal probe, etc.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caterina Gaudiano, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Caterina Gaudiano, MD

Role: CONTACT

caterina.gaudiano@aosp.bo.it

+39 0515142307

Facility Contacts

Caterina Gaudiano, MD

Role: primary

caterina.gaudiano@aosp.bo.it

39 0512142307

Other Identifiers

PROSTATE_01_2021

Identifier Type: -

Identifier Source: org_study_id