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MR Microstructural Imaging for Prostate Cancer Diagnosis

NCT07249281 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Zhejiang University

    collaborator OTHER

  • Jiangsu Provincial People's Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Dalian Medical University

    collaborator OTHER

  • Zhejiang Hospital

    collaborator OTHER

  • Henan Cancer Hospital

    collaborator OTHER_GOV

  • Beijing Hospital

    collaborator OTHER_GOV

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07249281 on ClinicalTrials.gov