Demonstration of the "SPECT/CT System With CZT Detectors" Imaging Performance in a Clinical Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Image Resolution
研究概览
简要总结
The primary purpose of the study is to obtain sample clinical images that are evaluated by physicians in support of regulatory submissions. Additionally, the study will provide data for current and future product development and it will provide clinical images and data for marketing use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •are 18-years old and older;
- •is able to sign and date the informed consent form; AND
- •have been prescribed by a physician a nuclear medicine exam that is within the intended use of the device.
排除标准
- •Patients who were referred for dynamic nuclear medicine scan because of the need to be injected twice (once for the conventional acquisition and once for the investigational device) that would result in an increase dose burden on patient.
- •Pregnant or lactating women
- •Who were previously enrolled in this study;
- •Who have contraindication for the radiopharmaceutical
- •Who have any conditions that, in the opinion of the Investigator, would interfere with the evaluation of the results or constitute a health hazard for the subject;
研究组 & 干预措施
Subjects indicated for dynamic nuclear medicine scanning
The trial will consist of a single arm composed of subjects with preexisting indications for dynamic nuclear medicine scanning at the site. All patients will undergo nuclear medicine scintigraphy using the GE Discovery 670 NM/CT device with and without CZT enabled during a single visit.
干预措施: Discovery NM/CT 670 CZT Imaging Scan (Device)
结局指标
主要结局
Image Resolution
时间窗: 12 weeks
Image Resolution will be rated by 2 radiologist using a 5 point Likert Scale
Diagnostic Image Quality
时间窗: 12 weeks
Diagnostic Image Quality will be rated by 2 radiologist using a 5 point Likert Scale
次要结局
未报告次要终点