Time-dependent diffusion MRI for prostate cancer microstructural imaging
Development of MR Microstructural Imaging Markers for Prostate Cancer Diagnosis and Investigation of the Associated Molecular Mechanisms
The team will test whether time-dependent diffusion MRI can help doctors more accurately diagnose prostate cancer in men who are suspected of having the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | Male |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 6 sites (Beijing, Beijing Municipality and 5 other locations) |
| Trial ID | NCT07249281 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multi-center diagnostic cohort in which men with suspected prostate cancer undergo standardized 3T multiparametric MRI that includes time-dependent diffusion MRI (TDDMRI) sequences. Quantitative microstructural parameters such as apparent cell size and cellularity will be derived from TDDMRI and compared directly with conventional mpMRI measures. Imaging findings will be validated against whole-slide histopathology from biopsy or prostatectomy, and harmonized imaging protocols across sites will support reproducibility. The investigators will develop and test diagnostic models that combine multiple imaging features to improve presurgical diagnosis across participating centers.
Who should consider this trial
Good fit: Men with clinical suspicion of prostate cancer (for example elevated PSA or abnormal digital rectal exam) who are scheduled for prostate MRI and willing to undergo biopsy or prostatectomy are ideal candidates.
Not a fit: Patients with prior prostate cancer treatment, contraindications to MRI, severe comorbidities, or poor image quality are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, TDDMRI-derived markers could improve detection of clinically significant prostate cancer and help reduce unnecessary procedures or misclassification.
How similar studies have performed: Early single-center and technical studies suggest TDDMRI can estimate tissue microstructure, but large multi-center validation for clinical diagnostic use is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality and 5 other locations
- Beijing Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University — Zhengzhou, Henan, China (Completed)
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital) — Nanjing, Jiangsu, China (Recruiting)
- The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Recruiting)
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
- Zhejiang Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Dan Wu, PhD
- Email: danwu.bme@zju.edu.cn
- Phone: +86 571 87951385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.