Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate Cancer
赞助:
ECOG-ACRIN Cancer Research Group
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | July 10, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | July 9, 2018 | ||
| 预计主要完成日期 | August 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score[ Time Frame: Up to 2 years ] Will estimate the diagnostic performance as quantified by the area under the ROC curve. Risk prediction model[ Time Frame: Up to 2 years ] To estimate the predictive performance of a model for predicting clinically significant prostate cancer on the basis of the overall PI-RADS, PSA, Gleason score and clinical stage. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate Cancer | ||
| 正式标题 ICMJE | Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer | ||
| 简要概况 | This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease. |
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| 详细说明 | PRIMARY OBJECTIVES: I. To estimate the diagnostic performance as quantified by the area under the ROC curve to detect aggressive prostate cancer. II. To develop a risk prediction model by incorporating overall PI-RADS, PSA, Gleason score and clinical stage to predict the presence of aggressive prostate cancer. SECONDARY OBJECTIVES: I. To evaluate the diagnostic performance of the individual PI-RADS score of each MRI parameter (T2W, DWI and DCE), as determined by local imaging review. TERTIARY OBJECTIVES: I. All clinical data including magnetic resonance (MR) images will be banked for future exploratory research aims. OUTLINE: Patients undergo mpMRI within 3 months prior to schedule surgery. After completion of study, patients are followed up until radical prostatectomy pathology is reported and finalized. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Diagnostic |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
852 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | August 1, 2025 | ||
| 预计主要完成日期 | August 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Recently diagnosed with prostate cancer for whom definitive surgical treatment is indicated Exclusion Criteria: - Not suitable to undergo MRI or receive gadolinium-based contrast agent (severe, untreatable claustrophobia; MRI-incompatible metallic objects or implanted medical devices; renal failure; weight greater than allowable by scanner per institutional standard practice) - Prior surgical and/or non-surgical treatment for prostate cancer - Prior hip replacement or other major pelvic surgery | ||
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: Yes |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | ECOG-ACRIN Cancer Research Group | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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