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临床试验/NCT02468609
NCT02468609Unknown不适用

Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT

Cantonal Hospital of St. Gallen1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Number of pulmonary Nodules detected in the Ultralow-Dose thoracic CT

研究概览

简要总结

To investigate the diagnostic value of ultralow-dose computed tomography in the detection of pulmonary nodules and lung parenchym alterations (e.g. emphysema) compared to standard-dose-CT.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •planned normal dose-CT by clinical indication at our institution
  • •obtained informed consent

排除标准

  • •planned lowdose-CT by clinical indication at institution
  • •no informed consent obtained
  • •age < 18 years
  • •pregnancy

研究组 & 干预措施

Ultralow-Dose-CT

Other

Additional Ultralow-Dose-CT of the chest

干预措施: Ultralow-Dose-CT (Radiation)

结局指标

主要结局

Number of pulmonary Nodules detected in the Ultralow-Dose thoracic CT

时间窗: Participants CT-scan will be read out on an average date of 6 weeks after the scan

Difference in nodule detectability in Ultralow-Dose-CT compared to Standard-Dose-CT measured using McNemar test

次要结局

  • Patients BMI (Body mass index)(Measures assessed at time of read-out on an average date of 6 weeks after the scan)
  • Patients Nodule size (mm)(Measures assessed at time of read-out on an average date of 6 weeks after the scan)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Messerli

MD

Cantonal Hospital of St. Gallen

研究点 (1)

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