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RECRUITING
NCT07249281

MR Microstructural Imaging for Prostate Cancer Diagnosis

Sponsor: First Affiliated Hospital of Zhejiang University

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.

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

Key Details

Gender

MALE

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2020-09-01

Completion Date

2028-12-31

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

MRI/ 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