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临床试验/NCT03162601
NCT03162601Unknown不适用

C-arm Computed Tomography Scan Image Quality in Patients With Neurovascular Diseases: Observational Study

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年4月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Number of participants with improved new CACT image quality compared to standard CACT based on a 5-point Likert scale

研究概览

简要总结

With new developments that have taken place in the optimization of C-arm computed tomography (CACT) image acquisition and reconstruction, CACT image quality will be better than current standard-of-care CACT scan techniques used for neurovascular patients referred to endovascular treatment or diagnosis. As such, novel acquisition, filtration, artifact reduction and reconstruction techniques will be evaluated against the standard-of-care CACT approach.

详细描述

This prospective observational study aims to enroll 50 patients diagnosed with various neurovascular conditions with the goal to compare the image quality of new types of head C-arm computed tomography (CACT) image scans with standard CACT scans, and also to compare these novel scans with standard CT scan image quality. These new scans use novel acquisition, filtration and reconstruction techniques compared to the standard-of-care CACT scans being used in the neuroangiography suite at the present time. Patient selection will be based on a suitability of patients for neuro-endovascular interventions in the neuroangiography suite. All research related activities will be done by study team members. The study patients are expected to follow their routine treatment schedule with the exception of 1 extra CACT scan while patient is receiving their standard treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Subject is suitable for an endovascular treatment in the neuro-angiography suite.
  • Subject or subject's legally authorized representative has signed an institutionally approved research informed consent form.
  • Subject ≥ 18 years old.

排除标准

  • Subject or subject's legally authorized representative is unable or unwilling to consent to the study.
  • Subject had prior significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications.
  • Subject with documented contrast injection contraindication due to severe kidney disease or allergy.

结局指标

主要结局

Number of participants with improved new CACT image quality compared to standard CACT based on a 5-point Likert scale

时间窗: 1 year

To achieve a brain parenchyma image quality with CACT using novel acquisition, filtration, artifact reduction and reconstruction techniques that is better than current standard-of-care CACT approaches, based on a 5-point Likert scoring scale questionnaire for each patient.

次要结局

  • Number of participants with improved or equivalent contrast-to-noise ratio using new CACT vs. standard CT scans(1 year)
  • Number of participants with a CACT image quality at the same level or better as standard CT based on a 5-point Likert scale(1 year)
  • Number of participants with improved contrast-to-noise ratio using new CACT vs. standard CACT(1 year)

研究者

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

Vitor Pereira

Associate Professor of Radiology and Surgery

University Health Network, Toronto

研究点 (1)

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