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Clinical Trials in Italy / NCT06774781
Recruiting Observational

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

NCT06774781 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2021-10-23
Last updated
2025-01-14

Condition(s) studied

Prostate Cancer (Adenocarcinoma)

Study 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?

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.)

Primary outcome measure(s)

  • Distribution of ADC — From enrollment to the end of treatment at 4 years
    Evaluate the distribution of ADC values of the prostatic lesions cataloged according to the criteria PI-RADSv2.1 ≥ 3, comparing it with the distribution of ADC values of the healthy glandular tissue, to define a predictive threshold value for clinically significant neoplastic lesion.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06774781 on ClinicalTrials.gov ↗ ← All trials in Italy