MR Microstructural Imaging for Prostate Cancer Diagnosis
Recruiting · NCT07249281 · Observational (researchers observe without assigning treatment) · Lead sponsor: First Affiliated Hospital of Zhejiang University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
6 locations listed.
- 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