Verification of Imaging System PCD-1000A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Confirm that PCD-1000A PET/CT System is Effective for Its Intended Use
研究概览
简要总结
Scope Verification of technologies included in the PCD-1000A PET/CT imaging chain.
- Define and confirm all supported clinical protocols
- Evaluate performance
详细描述
The study aim is system verification and associated software. Clinical data and clinical feedback will be used for verification.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients already scheduled for an FDG test at SDMI
- •40 years and older
- •Capable of providing their informed consent
排除标准
- •Patients not scheduled for an FDG test at SDMI
- •39 years or younger
- •Adult female patients that are and/or could become pregnant
- •Not capable of providing their informed consent
结局指标
主要结局
Confirm that PCD-1000A PET/CT System is Effective for Its Intended Use
时间窗: 3 months
PCD-1000A PET/CT system's performance will be evaluated for oncology PET imaging on cancer patients to verify that the system performs as expected. • Verify that all supported clinical protocols from PET acquisition, reconstruction, to presentation (filtering) perform as expected. Images acquired by PCD-1000A PET/CT will be compared with images acquired during a standard-of-care PET/CT scan by a commercially available PET/CT system just prior to imaging with the PCD-1000A PET/CT System. Image quality evaluation will include assessment of uniformity of the liver, delineation of the lungs, presence of artifacts and using Likert scale.
次要结局
未报告次要终点