Actively Recruiting

MALE
NCT07249281

MR Microstructural Imaging for Prostate Cancer Diagnosis

Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-11-25

2000

Participants Needed

6

Research Sites

434 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Zhejiang University

Lead Sponsor

Z

Zhejiang University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

MR Microstructural Imaging for Prostate Cancer Diagnosis

Who Can Participate

MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical suspicion of prostate cancer (elevated PSA, abnormal digital rectal examination, or other clinical indication)
  • Undergoing prostate MRI including TDDMRI as part of diagnostic evaluation
  • Able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Contraindications to MRI such as pacemaker, ferromagnetic implants, or severe claustrophobia
  • Prior treatment for prostate cancer including surgery, radiation, hormonal therapy, or chemotherapy
  • Severe health conditions preventing MRI or biopsy
  • Unable to provide informed consent
  • Poor MRI image quality due to motion or technical problems

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Beijing Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

2

Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, China

Completed

3

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

Nanjing, Jiangsu, China

Actively Recruiting

4

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Actively Recruiting

5

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

6

Zhejiang Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

D

Dan Wu, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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