Using MRI to identify prostate cancer 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
This study is testing if using special MRI scans can help doctors find prostate cancer lesions more accurately in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06774781 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of analyzing ADC values and radiomic characteristics from multiparametric MRI (mpMRI) images in detecting prostate cancer lesions. Participants will be enrolled at the IRCCS Azienda Ospedaliero-Universitaria in Bologna, where their informed consent and radiological data will be collected. The study will involve extracting ADC values from suspected lesions and healthy tissue, while radiomic features will be processed by medical physicists and engineers. The goal is to determine if these imaging analyses can improve the detection of prostate cancer.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with lesions classified as PI-RADSv2.1 ≥ 3 who are indicated for targeted biopsy or radical prostatectomy.
Not a fit: Patients who cannot undergo MRI due to claustrophobia, obesity, or other contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer detection, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using radiomics and MRI for cancer detection, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Caterina Gaudiano, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Caterina Gaudiano, MD
- Email: caterina.gaudiano@aosp.bo.it
- Phone: +39 0515142307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.