Pilot Study for Simultaneous PET-MR Imaging of Covid-19 Associated Neurological Complications Using a Brain Dedicated PET Insert
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Image quality of PET/MR
研究概览
简要总结
The primary goal of this project is to study the feasibility of a prototype brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of metabolism and perfusion in Covid-19 negative and positive/once positive subjects. This study serves as a pilot study for establishing an imaging protocol for combined PET and MR derived functional information as well as MRI acquired anatomical information.
详细描述
This study is a non-randomized non-treatment study. The intention of this work is an assessment of the PET insert technology, and not, for example, to perform a treatment assessment or drug assessment. This work will actively recruit 10 individuals (5 Covid-19 negative and 5 Covid-19 previously positive in the last 180 days) to perform imaging of the brain with an FDA-approved radiotracer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Whole body radiation dose in the last year of less than 5000 mrem determined via subject verbal history reporting
- •Must be at least 21 years of age
- •Deemed healthy to endure duration of imaging study as confirmed via study PI
- •Proof of COVID-19 viral or antibody testing within the timeframe of >20 days but <=180 days prior to scan.
排除标准
- •History of non-MRI compatible surgeries, implants, or activities
- •Pregnant or nursing
- •History of allergic reactions to PET radiotracers (via patient verbal report and /or medical record review.
研究组 & 干预措施
Covid-19 Positive/Infected Population
5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.
干预措施: Injected radiotracer with PET Insert (Diagnostic Test)
Covid-19 Negative/Uninfected Population
5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.
干预措施: Injected radiotracer with PET Insert (Diagnostic Test)
结局指标
主要结局
Image quality of PET/MR
时间窗: Up to 24 months
The key specific measurement is that resulting PET/MR images are of high quality, with comparable or better resolution and noise than that seen in other published articles.
次要结局
未报告次要终点
研究者
Craig Levin
Professor, Radiology/Nuclear Medicine
Stanford University