CT剂量合作实验室
2024年3月5日 更新者：University of California, San Francisco
CT 剂量优化和标准化努力 (DOSE) 合作实验室
这是一项实用的阶梯楔形集群随机对照试验，旨在通过汇集不同医疗服务系统的辐射剂量数据来探索用于诊断 CT 的剂量变化。
比较降低和优化剂量的不同策略，并确定实施成功剂量优化策略和标准化实践的障碍和促进因素。
研究概览
详细说明
研究人员正在使用阶梯楔形集群随机对照试验，从所有合作的医疗保健机构收集 CT 辐射剂量信息，并领导几种不同的干预措施来优化机构间的剂量。 除了收集 CT 辐射剂量数据，并利用这些结果向合作的医疗保健机构提供反馈外，他们还将在每个站点对几个人进行调查，包括主要线人，如首席放射科医生、技术专家和医学物理学家和放射科管理员。
他们将比较和确定与成功和失败的剂量优化实施相关的促进因素和障碍（通过参与设施的调查评估）。
研究类型
介入性
注册 (实际的)
864080
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 99年 (孩子、成人、年长者)
接受健康志愿者
是的
描述
纳入标准：
- 在研究期间进行的头部、胸部和/或腹部/骨盆的诊断性 CT 扫描
排除标准：
- 不是头部、胸部和/或腹部/骨盆的非诊断性扫描
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：A轨
简单的审计报告；面对面会议（时间与多方干预一致）；多成分干预
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简单的审计提供辐射剂量的比较和反馈。
多组件干预针对所需的更改提供量身定制的反馈，并使用促进组织更改的质量改进方法提供指导。
提供对专家的访问、详细的审计、协作呼叫和现场访问（根据需要）。
强调质量改进的合作者会议。
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有源比较器：B轨
面对面会议（时间与简单审计报告一致）；简单的审计报告；多成分干预
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简单的审计提供辐射剂量的比较和反馈。
多组件干预针对所需的更改提供量身定制的反馈，并使用促进组织更改的质量改进方法提供指导。
提供对专家的访问、详细的审计、协作呼叫和现场访问（根据需要）。
强调质量改进的合作者会议。
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其他：C轨
简单的审计报告；多成分干预
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简单的审计提供辐射剂量的比较和反馈。
多组件干预针对所需的更改提供量身定制的反馈，并使用促进组织更改的质量改进方法提供指导。
提供对专家的访问、详细的审计、协作呼叫和现场访问（根据需要）。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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平均有效剂量 (ED) 的变化
大体时间：地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
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我们将评估简单审计和多成分干预（MCI）后与审计和多成分干预前相比平均有效剂量的变化。
下面给出的数字反映了平均剂量（以毫西弗为单位）相对于基线期的绝对变化。
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地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
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有效剂量高于基准的 CT 扫描百分比
大体时间：地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
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我们将评估简单审核后和多成分干预（MCI）后有效剂量高于基准的检查百分比与审核前和 MCI 剂量相比的变化。
每个解剖区域的基准定义为干预前（基线）期间剂量分布的第 75 个百分位。
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地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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平均剂量长度乘积
大体时间：地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
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我们将评估审核和 MCI 后剂量长度乘积与审核和 MCI 之前相比的变化。
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地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
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剂量长度乘积高于基准的 CT 扫描比例
大体时间：地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
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我们将评估审核后和 MCI 后剂量长度乘积高于基准的检查比例与审核前和 MCI 之前的剂量相比的变化。
每个解剖区域的基准定义为干预前期间剂量分布的第 75 个百分位。
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地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
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平均体积计算机断层扫描剂量指数 (CTDIvol) 的变化
大体时间：地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
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我们将评估审计和 MCI 干预前后平均体积 CT 剂量指数 (CTDIvol) 的变化。
CTDIvol（以毫格雷为单位，mGy）是辐射剂量的度量，反映扫描仪对每个 CT 切片发出的辐射量。
CTDIvol 越高意味着辐射剂量越大。
一般来说，CTDIvol 的减少是质量改善的标志，可以最大限度地减少患者的过度辐射暴露。
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地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
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CTDIvol 高于基准的 CT 扫描百分比
大体时间：地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
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我们将评估审核后和多成分干预后 CTDIvol 高于基准的检查百分比与审核和多成分干预前的剂量相比的变化。
每个解剖区域的基准定义为干预前期间剂量分布的第 75 个百分位。
|
地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
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平均器官剂量的变化：头部 CT 的脑剂量；胸部 CT 肺剂量；腹部 CT 结肠和肝脏剂量
大体时间：地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
|
我们将评估简单审核和多成分干预（MCI）后与审核和多成分干预前相比器官剂量的变化。
下面给出的数字反映了平均剂量（以毫西弗为单位）相对于基线期的绝对变化。
|
地点被随机分配到 3 个轨道中的一个，这决定了干预的时间： 轨道 A：在第 40 周审核，MCI 在第 68 周 轨道 B：在第 44 周审核，MCI 在第 74 周 轨道 C：在第 53 周审核，MCI 在第 74 周第 81 周
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Rebecca Smith-Bindman, MD、University of California, San Francisco
- 首席研究员：Judy Yee, MD、San Francisco Veterans Administration
- 首席研究员：Tom Nelson, PhD、University of California, San Diego
- 首席研究员：Tony Seibert, PhD、University of California, Davis
- 首席研究员：Mayil Krishnam, MD、University of California, Irvine
- 首席研究员：Michael Flynn, PhD、Henry Ford Health System
- 首席研究员：Mary Cocker, MSc, Csci、Oxford University Hospitals NHS Trust
- 首席研究员：William Boswell, MD、City of Hope Medical Center
- 首席研究员：Sebastian Schindera, MD、University Hospital of Basel
- 首席研究员：Erin Bell, MHP、Community Health Network
- 首席研究员：Phuong-Anh Duong, MD、Emory University
- 首席研究员：Nima Kasraie, PhD, MSc、Children's Mercy Hospital Kansas City
- 首席研究员：Pavlina Pike, PhD、Huntsville Hospital
- 首席研究员：Luisa Cervantes, MD、Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- 首席研究员：Joachim Wildberger, PhD、Maastricht University Medical Center
- 首席研究员：Michael Forsting, MD、University of Duisburg-Essen
- 首席研究员：Fady Kassem, PhD、St. Joseph Hospital of Orange
- 首席研究员：Darrell Fendrick, CT、East Texas Medical Center
- 首席研究员：Sugoto Mukherjee, MD、University of Virginia Health System
- 首席研究员：Brad Delman, MD、Icahn School of Medicine at Mount Sinai
- 首席研究员：Jodi Roehm、Center For Diagnostic Imaging
- 首席研究员：Anokh Pahwa, MD、Olive View - UCLA
- 首席研究员：Ryan Lee, MD, MBA、Einstein Medical Center
- 首席研究员：Jay Starkey, MD、St. Luke's International Hospital, Tokyo
- 首席研究员：Diana Miglioretti, PhD、University of California, Davis
- 首席研究员：Saravanabavaan Suntharalingam, MD、University of Duisburg-Essen
- 首席研究员：Sara Lewis, MD、Icahn School of Medicine at Mount Sinai
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年7月1日
初级完成 (实际的)
2020年12月1日
研究完成 (实际的)
2020年12月1日
研究注册日期
首次提交
2016年12月12日
首先提交符合 QC 标准的
2016年12月19日
首次发布 (估计的)
2016年12月22日
研究记录更新
最后更新发布 (实际的)
2024年3月8日
上次提交的符合 QC 标准的更新
2024年3月5日
最后验证
2024年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
简单审计报告的临床试验
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Boston Scientific Corporation完全的胆道狭窄 | 壶腹周围肿瘤 | 胆总管结石引起的胆道梗阻 | 胆道出血香港, 大韩民国, 泰国, 澳大利亚, 沙特阿拉伯, 日本, 印度, 巴基斯坦, 新加坡, 南非
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Institut für Diabetes-Technologie Forschungs- und...Bayer完全的
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Region StockholmKarolinska Institutet; Forte; Sophiahemmet University招聘中
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The University of Hong Kong招聘中