RecruitingNCT07249281

MR Microstructural Imaging for Prostate Cancer Diagnosis

Development of MR Microstructural Imaging Markers for Prostate Cancer Diagnosis and Investigation of the Associated Molecular Mechanisms


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

2,000 participants

Start Date

Sep 1, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this multi-center clinical study is to evaluate whether time-dependent diffusion MRI (TDDMRI) can provide reliable microstructural imaging markers for the diagnosis of prostate cancer. The main questions this study aims to answer are: * Do TDDMRI-derived microstructural parameters (such as cell size and density) improve diagnostic accuracy for prostate cancer compared with conventional MRI? * How well do the microstructural parameters correlate with whole-slide pathology findings? * Can the investigators determine diagnostic models combining multiple features for presurgical diagnosis across multiple centers? Participants with suspected prostate cancer will undergo 3T MRI including TDDMRI. Microstructural parameters will be quantified and compared with standard multiparametric MRI. All participants will also receive prostate biopsy or prostatectomy, and imaging findings will be validated against histopathology. This study will: * Collect TDDMRI and conventional MRI data from six hospitals. * Derive and validate imaging markers of prostate cancer based on microstructural parameters. * Compare diagnostic performance across centers and against pathology as the reference standard.


Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study evaluates a specialized type of MRI scan called TDDMRI (tissue diffusion-based MRI) that may help detect and diagnose prostate cancer more accurately without requiring an invasive biopsy. Researchers are comparing the scan results to biopsy findings to see how reliable the imaging is. **You may be eligible if...** - You have a clinical reason to suspect prostate cancer (such as a high PSA blood test or an abnormal digital rectal exam) - You are scheduled to receive a prostate MRI as part of your diagnostic evaluation - You are able and willing to provide written consent **You may NOT be eligible if...** - You cannot safely undergo an MRI (e.g., you have a pacemaker, metal implants, or severe claustrophobia) - You have already received treatment for prostate cancer (surgery, radiation, hormone therapy, or chemotherapy) - You have serious health conditions that prevent you from having an MRI or biopsy - The MRI images are of poor quality due to movement or technical issues Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTMRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

The investigators will compare the diagnostic power of the proposed time-dependent diffusion MRI technique with conventional multiparameter MRI for prostate diagnosis


Locations(6)

Beijing Hospital

Beijing, Beijing Municipality, China

Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, China

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

Nanjing, Jiangsu, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Hospital

Hangzhou, Zhejiang, China

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NCT07249281


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