A Comparison of Static and Dynamic PET/CT in Patients With Malignancies, Infections and Inflammatory Diseases (HYPOTHESIS Generation Study)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Obtaining a database of parametric and traditional static PET/CT images for comparison of visual and semiquantitative evaluation
研究概览
简要总结
The general purpose of this initial study is to evaluate whether parametric PET/CT improves diagnosis and treatment monitoring in select diseases. The specific aim of the HYPOTHESIS GENERATION study is:
- To obtain and compare parametric as well as traditional static PET/CT images and determine the number of lesions identified on each type of scan.
详细描述
The hypothesis generating study will include a wide range of patients scheduled for PET/CT as part of either pre-therapy staging or treatment response.
Most scans will be performed with FDG, with indications for PET/CT including hematological, urogenital, thoracic and gynecological malignancies as well as patients with suspected infections and inflammation. We will also include patients referred for PET/CT using other radiotracers, such as tumour markers (68Ga-DOTATOC, 18F-FDOPA, 68Ga-PSMA, 18F-PSMA).
Instead of the usual procedure of having the injection of the radiotracer in the waiting room and having to wait 60 minutes before being moved to the scanner room for imaging, the study participants will be injected with the radiotracer already laying on the scanner bed and the scan will commence immediately.
Therefore, in this study the patients are still only being scanned once, but we are gathering PET information in a different way.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a planned clinical standard PET/CT as part of pre-therapeutic staging, response assessment scanning or evaluation of infection/inflammation.
- •Good performance status, which permits patients to lay still in the scanner for ca. 70 min.
排除标准
- •Age < 18 or > 85 years
- •Patients that can not tolerate a PET scan (f.ex: claustrophobia).
结局指标
主要结局
Obtaining a database of parametric and traditional static PET/CT images for comparison of visual and semiquantitative evaluation
时间窗: through study completion, average 1 year
We will perform a correlation of the image derived from parametric PET/CT with those obtained from static PET/CT. This will allow us to evaluate if there are clinical advantages in regards to using parametric PET in clinical routine.
次要结局
未报告次要终点
研究者
André H. Dias
Principal Investigator
Aarhus University Hospital