PET/CT in Infection and Inflammation Imaging: Current Utility and Future Perspectives (The PIN-UP Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
The overall aim is to validate the current use of FDG PET/CT for the diagnosis of infection and inflammation and examine the usefulness of PET/CT applying also other tracers.
The results should allow us to confirm our primary hypothesis: "FDG-PET/CT is better than established methods to confirm or exclude the diagnosis of infection/inflammation".
详细描述
The study include several part projects, each contributing to the evaluation of the value of FDG-PET/CT in the diagnosis of infection and inflammation. The aims are to establish the diagnostic value in terms of sensitivity, specificity, positive and negative predictive values, interobserver and intraobserver variation.
Part project A FDG-PET/CT in patients with blood culture positive for staphylococcus aureus and unresolved origin of infection.
Part project B FDG-PET/CT in patients with fever of unknown origin.
Part project C FDG-PET/CT in patients suspected of vascular graft infection.
Additionally, we wish to establish an optimal imaging protocol (necessity of fasting, consequences of antibiotic therapy prior to imaging, and the need of contrast), interpretation criteria, and the value of standard uptake values (SUV).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Part project A
- •Blood culture positive for staphylococcus aureus and unresolved origin of infection.
- •Part project B
- •Fever of unknown origin
- •Referred for FDG-PET/CT at the Department of Nuclear Medicine, Odense University Hospital.
- •Part project C
- •Suspected vascular graft infection
- •Referred for FDG-PET/CT at the Department of Nuclear Medicine, Odense University Hospital.
排除标准
- •Patients incapable of giving, refusing or revoking consent
- •Patients less than 18 years of age
- •Patients from other regions than the Region of Southern Denmark
- •Patients who cannot cooperate to PET/CT scan.
结局指标
主要结局
Efficacy
时间窗: During diagnostic workup
Diagnostic parameters of FDG-PET/CT (ie. sensitivity, specificity, positive and negative predictive values, accuracy.
次要结局
未报告次要终点
研究者
Søren Hess, MD
MD
Odense University Hospital