MR Microstructural Imaging for Prostate Cancer Diagnosis

Recruiting now

Conditions studied: Prostate Cancer, Diffusion MRI

In brief

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.

Key facts

Study ID

NCT07249281

Run by

First Affiliated Hospital of Zhejiang University

People needed

2000

Starts

2020-09-01

Expected to finish

2028-12-31

Last updated by the study team

2025-11-25

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Beijing Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital) — Nanjing, Jiangsu, China (enrolling)
• The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (enrolling)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
• Zhejiang Hospital — Hangzhou, Zhejiang, China (enrolling)
• Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University — Zhengzhou, Henan, China

Full record on ClinicalTrials.gov

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