CARESTREAM Vue PACS v12.1.5 CT Perfusion Clinical Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- To compare the diagnostic value of CTP in CARESTREAM Vue PACS ("investigational device") to the Olea Sphere PACS with CT Perfusion Module ("predicate device").
研究概览
简要总结
The purpose of this clinical study is to evaluate the CARESTREAM Vue PACS 12.1.5 Computed Tomography (CT) Perfusion ("investigational device") imaging performance. Evaluation of CT Perfusion (CTP) imaging will compare CTP with the predicate device, the Olea Sphere PACS with CT Perfusion Module.
详细描述
This study will demonstrate the imaging performance CTP by an assessment of 30 CTP de-identified patient cases collected retrospectively. The purpose of the study is to demonstrate equivalent clinical quality between the investigational and predicate devices using a radiologist evaluation of key metrics which are applicable to CTP images.
The maps include the following:
- Mean Transfer Time (MTT) - the time that the contrast material stays in the tissue
- Cerebral Blood Volume (CBV) - the volume of blood that is in a known volume of the tissue based on the concentration of contrast material that is in the tissue over the time
- Cerebral Blood Flow (CBF) - describes the flow of the blood to the affected tissue
- Time To Peak (TTP) - the time that maximum enhancement is achieved at each volume of the tissue
- Time to maximum of impulse response function (TMAX)
The retrospective data collected for each patient will include a non-contrast head CT exam completed on the same day as CTP image, and a follow-up head CT at least 1-2 days after the initial imaging study (initial non-contrast head CT) if available.
Similar performance between the investigational and predicate devices was demonstrated by the following criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retrospective patient CTP cases with case maps that include the following information: MTT, CBV, CBF, TTP, and TMAX.
- •Initial CT exam and CT exam 1-2 days after the initial exam if available, and
- •Retrospective CTP case with subject/patient 18 years of age or older
排除标准
- •Low quality images, or images that are not clinically acceptable for clinical diagnostic reading as determined by the Principal Investigator,
- •Subject less than 18 years of age
结局指标
主要结局
To compare the diagnostic value of CTP in CARESTREAM Vue PACS ("investigational device") to the Olea Sphere PACS with CT Perfusion Module ("predicate device").
时间窗: one month
Demonstrate equivalent clinical quality between the investigational and predicate devices.
次要结局
未报告次要终点