Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Image quality
研究概览
简要总结
The purpose of this study is to assess new low radiation dose techniques for clinical PET/CT scans through intra-individual comparison between a clinical, standard dose scan and a low-dose scan, completed within one week of each other.
详细描述
Positron Emission Tomography/Computed Tomography (PET/CT) imaging using 18F-FDG is an important, commonly used cancer, neuroscience and cardio-vascular imaging methodology to detect disease and to monitor therapeutic interventions. While considerable technological progress of PET/CT systems has occurred over the last decade, we have not re-evaluated the ability to potentially reduce the radiation burden of the used PET imaging pharmaceutical (FDG).
This early phase trial intends to accomplish the following:
- to validate that the radiation dose burden from the PET imaging pharmaceutical (FDG) can be reduced by more than 50% from the current standard of clinical care (SOC) level without affecting the diagnostic ability;
- to confirm that a low dose approach will be feasible for response assessment;
- to validate that the difference in FDG uptake between imaging 60 min +/- 10 min post injection and 75 min +/- 10 min post injection is independent/equivalent of the injected FDG dose
- to validate a simulation methodology to streamline future dose finding studies for PET imaging pharmaceuticals.
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
- •Male and female patients greater than or equal to 18 years of age
- •Patients scheduled for a standard of care PET/CT scan
- •For female patients of child-bearing potential, the OSUWMC requirements for receiving the standard of care PET imaging agent and CT examination needs to be met
排除标准
- •Participants who are pregnant or lactating
- •Prisoners
- •Participants incapable of giving informed consent
- •Patients unable to lie flat on the scanner for extended periods of time
结局指标
主要结局
Image quality
时间窗: through study completion, on average 2-5 years
assessed by blinded readers
次要结局
- Artifacts(through study completion, on average 2-5 years)
- Lesion detectability(through study completion, on average 2-5 years)
- Image noise(through study completion, on average 2-5 years)
研究者
Michael V Knopp MD PhD
Professor
University of Cincinnati