Clinical trial · Observational
MR Microstructural Imaging for Prostate Cancer Diagnosis
Development of MR Microstructural Imaging Markers for Prostate Cancer Diagnosis and Investigation of the Associated Molecular Mechanisms
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffusion MRI | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Prostate Cancer Suspected Cohort
- description
- 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 imaging data for exploratory analyses.
- interventionNames
- Diagnostic Test: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)
Primary outcomes (2)
- measure
- Diagnostic Accuracy of TDDMRI for Clinically Significant Prostate Cancer (csPCa)
- timeFrame
- Within 3 months after MRI and pathology confirmation.
- description
- 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).
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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).
References
Publications (0)
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