Actively Recruiting
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
Eligibility Criteria
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
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
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
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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