Demonstration Of A Next Generation PET CT System (OMNI dBGO)
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Evaluation- Likert Scale
研究概览
简要总结
The intent of this evaluation is to obtain user feedback on device performance, user preference, image quality, workflow, and new device features, a necessary part of product development. This study will also help to inform protocol development in reducing both scan time and/or radiologic tracer dose. The goal of this study is to collect a library of image data from the hybrid PET/CT system to be used for evaluation and optimization of the image quality of the system in a clinical setting and as comparison with the standard of care hybrid PET/CT system, Discovery MI 25m (DMI5R).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult, who is at least 18 years of age;
- •A clinical indication for PET/CT examination according to current clinical practice standards;
- •Able and willing to provide informed consent for participation in this study
排除标准
- •Diabetic patient with a glucose level ≥ 150 mg/dl at the time of the exam (for FDG) or,
- •Known to be pregnant or breastfeeding (the investigational site will follow their standard practice of verifying for women of childbearing age. No study specific pregnancy test will be performed for this study); or,
- •Previously enrolled in this study.
结局指标
主要结局
Evaluation- Likert Scale
时间窗: through study completion, an average of 1 year
The primary endpoints of this study are completed image evaluation using a 1 point Likert Scale of the OMNI PET/CT system including analysis, reading, and scoring utilizing a Likert Scale, by three (3) qualified Nuclear Medicine physicians.
次要结局
- Data Collection(through study completion, an average of 1 year)