Clinical Trial

MR Microstructural Imaging for Prostate Cancer Diagnosis

Recruiting
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07249281
Lead Sponsor First Affiliated Hospital of Zhejiang University
Collaborators: Zhejiang University, Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Dalian Medical University, Zhejiang Hospital, Henan Cancer Hospital, Beijing Hospital
Conditions Prostate Cancer, Diffusion MRI
Enrollment 2,000 participants
Start Date 2020-09-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-25