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

Inclusion Criteria2

  • 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.

Exclusion Criteria5

  • Contraindications to MRI (e.g., pacemaker, ferromagnetic implants, severe claustrophobia).
  • Prior treatment for prostate cancer (surgery, radiation, hormonal therapy, chemotherapy).
  • Severe comorbid conditions precluding MRI or biopsy.
  • Inability to provide informed consent.
  • Poor image quality due to motion or technical artifacts (assessed at imaging QC).

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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