Clinical Evaluation of a Dual Energy CT System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Raw CT Scan Data
研究概览
简要总结
The main purpose of this study is to collect clinical raw scan data and Scanner user feedback using dual energy CT (computed tomography) scan modes on the investigational CT scanner. Additionally, image quality using prototype reconstruction algorithms that are in development will be evaluated and compared to standard-of-care images acquired with regulatory cleared diagnostic CT scanners for feasibility assessment and engineering development. Compared to standard clinical single energy (kilovolt,kV) scanning, dual energy (kV) scanning s provides more information about the material composition of the scanned patient and may allow for improved tissue, tumor characterization, and improved image quality.
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
- None
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
- •Who are 18 year of age or older;
- •Able to sign and date the informed consent form; AND
- •Who have in the past year undergone a clinically-indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities
排除标准
- •Who are pregnant or lactating;
- •Who were previously enrolled in this study;
- •For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents;
- •For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
- •Who are in need of urgent or emergent care;
- •Diabetic patients on metformin (Glucophage)
- •Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; AND
- •Who are unwilling to have GEHC personnel present for the CT exam
结局指标
主要结局
Raw CT Scan Data
时间窗: 3 months
No outcome assessment is currently planned. Up to 60 subjects will be scanned using GE Healthcare's Revolution CT scanner for future engineering and regulatory purposes.
次要结局
- Image Quality assessment(3 months)