Development of MR Microstructural Imaging Markers for Prostate Cancer Diagnosis and Investigation of the Associated Molecular Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 6
- 主要终点
- Diagnostic Accuracy of TDDMRI for Clinically Significant Prostate Cancer (csPCa)
研究概览
简要总结
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.
详细描述
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 MRI (TDDMRI) is an advanced technique that probes water diffusion over different diffusion times, thereby providing sensitivity to tissue microstructural features such as cell size, cellularity, and transmembrane water exchange. These parameters may serve as novel imaging biomarkers for PCa and could improve diagnostic accuracy beyond what is currently achievable with standard MRI techniques.
This is a multi-center diagnostic cohort study with prospective enrollment of suspected PCa participants, along with pathology data. The study is designed to evaluate the clinical utility of TDDMRI for PCa detection, with a focus on developing and validating MR microstructural imaging markers and establish a robust diagnostic model that is generalizable to most clinical settings.
Study Procedures Participants with clinical suspicion of prostate cancer will undergo standardized MRI examinations that include both conventional mpMRI and TDDMRI sequences. Imaging protocols will be harmonized across participating centers to ensure reproducibility of microstructural parameter estimation. Quantitative markers such as cellularity, cell size, and diffusivity metrics will be derived from TDDMRI data.
Histopathological confirmation through prostate biopsy or prostatectomy will be obtained in a subset of participants who provide informed consent. For these cases, imaging-derived microstructural parameters will be directly compared with histological measures. For participants without available pathology, imaging data will still be retained and analyzed for exploratory purposes and for cross-center reproducibility assessments.
Quality Assurance and Data Management
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Diagnostic Accuracy of TDDMRI for Clinically Significant Prostate Cancer (csPCa)
时间窗: Within 3 months after MRI and pathology confirmation.
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).
Development of Imaging-Based Diagnostic Criteria
时间窗: Within 3 months (at completion of enrollment and pathology confirmation).
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.
次要结局
- Cross-Center Reproducibility(After completion of enrollment across all centers (up to 24 months).)
- Sensitivity and Specificity of TDDMRI(Within 3 months after MRI and pathology confirmation.)
- Comparison with Conventional mpMRI(Within 3 months after MRI and pathology confirmation.)
- Correlation with Gleason Score(Within 3 months after MRI scan)