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Clinical Trial NCT07249281 for Prostate Cancer, Diffusion MRI is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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MR Microstructural Imaging for Prostate Cancer Diagnosis 2,000 Multi-Center
Clinical Trial NCT07249281 is an observational study for Prostate Cancer, Diffusion MRI that is recruiting. It started on 1 September 2020 with plans to enroll 2,000 participants. Led by First Affiliated Hospital of Zhejiang University, it is expected to complete by 31 December 2028. The latest data from ClinicalTrials.gov was last updated on 25 November 2025.
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...
Detailed Description
Prostate cancer is one of the most common malignancies among men worldwide, and accurate diagnosis is crucial for treatment planning and outcome prediction. Conventional multiparametric MRI (mpMRI) has become an important tool in prostate cancer (PCa) diagnosis; however, its diagnostic performance remains suboptimal, e.g., for differentiating clinically significant from insignificant disease. Time-dependent diffusion...Show More
Official Title
Development of MR Microstructural Imaging Markers for Prostate Cancer Diagnosis and Investigation of the Associated Molecular Mechanisms
Conditions
Prostate CancerDiffusion MRIOther Study IDs
- [2025B] IIT.No. 0321
NCT ID Number
Start Date (Actual)
2020-09-01
Last Update Posted
2025-11-25
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
2,000
Study Type
Observational
Status
Recruiting
Keywords
Prostate Cancer
Time-dependent Diffusion MRI (TDDMRI)
Diagnostic Accuracy
Multi-center Study
Time-dependent Diffusion MRI (TDDMRI)
Diagnostic Accuracy
Multi-center Study
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Prostate Cancer Suspected Cohort Men with clinical suspicion of prostate cancer who undergo standardized MRI including time-dependent diffusion MRI (TDDMRI). Histopathological confirmation (biopsy or prostatectomy) will be obtained in a subset of participants who provide consent. Diagnostic accuracy of TDDMRI-derived microstructural markers will be evaluated against pathology when available. Participants without pathology will still contribute imagi...Show More | MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy) The investigators will compare the diagnostic power of the proposed time-dependent diffusion MRI technique with conventional multiparameter MRI for prostate diagnosis |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Diagnostic Accuracy of TDDMRI for Clinically Significant Prostate Cancer (csPCa) | Area under the receiver operating characteristic curve (AUC, range 0-1; higher values indicate better diagnostic performance) for TDDMRI-derived microstructural parameters to detect csPCa (reference standard: histopathology; Gleason score ≥7). | Within 3 months after MRI and pathology confirmation. |
Development of Imaging-Based Diagnostic Criteria | Establishment of threshold values or decision rules for TDDMRI-derived microstructural parameters (e.g., cellularity, cell size index, diffusivity) to differentiate malignant from benign prostate tissue. Diagnostic cutoffs will be derived by ROC analyses and validated against histopathology. | Within 3 months (at completion of enrollment and pathology confirmation). |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Cross-Center Reproducibility | Agreement of TDDMRI-derived parameters across participating centers, assessed by intraclass correlation coefficient (ICC; range 0-1, higher indicates better reproducibility). | After completion of enrollment across all centers (up to 24 months). |
Sensitivity and Specificity of TDDMRI | Sensitivity and specificity (0-100%; higher indicates better diagnostic performance) of TDDMRI-derived microstructural parameters in identifying clinically significant prostate cancer. | Within 3 months after MRI and pathology confirmation. |
Comparison with Conventional mpMRI | Difference in diagnostic performance (AUC, sensitivity, specificity) between TDDMRI parameters and conventional mpMRI measures : apparent diffusion coefficient (ADC) and Prostate Imaging-Reporting and Data System, version 2.1 (PI-RADS v2.1; score 1-5, higher indicates a higher likelihood of csPCa). | Within 3 months after MRI and pathology confirmation. |
Correlation with Gleason Score | Correlation between TDDMRI microstructural parameters (e.g., cellularity, cell size index) and Gleason score from pathology, using Spearman's ρ (range -1 to 1; larger magnitude indicates stronger monotonic association), with 95% confidence intervals. | Within 3 months after MRI scan |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
Male
- 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.
- 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).
First Affiliated Hospital of Zhejiang UniversityStudy Central Contact
Contact: Dan Wu, PhD, +86 571 87951385, [email protected]
6 Study Locations in 1 Countries
Beijing Municipality
Beijing Hospital, Beijing, Beijing Municipality, China
Chunmei Li, Contact, 86-15811011208, [email protected]
Recruiting
Henan
Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, Henan, China
Completed
Jiangsu
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Nanjing, Jiangsu, China
Yudong Zhang, PhD, Contact, +86 25 83714511
Recruiting
Liaoning
The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
Ailian Liu, PhD, Contact, +86 411 83635963, [email protected]
Recruiting
Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China
Xiangyi Zheng, PhD, Contact, +86 571 87236832, [email protected]
Recruiting
Zhejiang Hospital, Hangzhou, Zhejiang, China
Jianjun Zhang, Contact, 86+13735882084, [email protected]
Recruiting