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O estudo clínico NCT07249281 para Câncer de próstata, Diffusion MRI está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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MR Microstructural Imaging for Prostate Cancer Diagnosis 2.000 Multicêntrico
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07249281 é um estudo observacional para Câncer de próstata, Diffusion MRI. Seu status atual é: em recrutamento. O estudo começou em 1 de setembro de 2020 e pretende incluir 2.000 participantes. Coordenado por First Affiliated Hospital of Zhejiang University e deve ser concluído em 31 de dezembro de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 25 de novembro de 2025.
Resumo
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...
Descrição detalhada
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...Mostrar mais
Título oficial
Development of MR Microstructural Imaging Markers for Prostate Cancer Diagnosis and Investigation of the Associated Molecular Mechanisms
Condições médicas
Câncer de próstataDiffusion MRIOutros IDs do estudo
- [2025B] IIT.No. 0321
Número NCT
Data de início (real)
2020-09-01
Última atualização postada
2025-11-25
Data de conclusão (estimada)
2028-12-31
Inscrição (estimada)
2.000
Tipo de estudo
Observacional
Status
Em recrutamento
Palavras-chave
Prostate Cancer
Time-dependent Diffusion MRI (TDDMRI)
Diagnostic Accuracy
Multi-center Study
Time-dependent Diffusion MRI (TDDMRI)
Diagnostic Accuracy
Multi-center Study
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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...Mostrar mais | 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 |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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). |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto, Idoso
Sexos elegíveis
Masculino
- 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 UniversityContato central do estudo
Contato: Dan Wu, PhD, +86 571 87951385, [email protected]
6 Locais do estudo em 1 países
Beijing Municipality
Beijing Hospital, Beijing, Beijing Municipality, China
Chunmei Li, Contato, 86-15811011208, [email protected]
Em recrutamento
Henan
Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, Henan, China
Concluído
Jiangsu
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Nanjing, Jiangsu, China
Yudong Zhang, PhD, Contato, +86 25 83714511
Em recrutamento
Liaoning
The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
Ailian Liu, PhD, Contato, +86 411 83635963, [email protected]
Em recrutamento
Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China
Xiangyi Zheng, PhD, Contato, +86 571 87236832, [email protected]
Em recrutamento
Zhejiang Hospital, Hangzhou, Zhejiang, China
Jianjun Zhang, Contato, 86+13735882084, [email protected]
Em recrutamento