NCT07249281 MR Microstructural Imaging for Prostate Cancer Diagnosis
| NCT ID | NCT07249281 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2020-09-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07249281 clinical trial?
This trial is open to male participants only, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07249281 currently recruiting?
Yes, NCT07249281 is actively recruiting participants. Contact the research team at danwu.bme@zju.edu.cn for enrollment information.
Where is the NCT07249281 trial being conducted?
This trial is being conducted at Beijing, China, Zhengzhou, China, Nanjing, China, Dalian, China and 2 additional locations.
Who is sponsoring the NCT07249281 clinical trial?
NCT07249281 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 2,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.