EXPLORER PET/CT: Evaluation of Healthy Individuals From Racial/Ethnic Minority Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
研究概览
简要总结
The objective of this pilot study is to collect preliminary data using total body scans on a new, first of its kind, FDA 510k-cleared positron emission tomography/computed tomography (PET/CT) scanner, called EXPLORER. The study will aim to recruit healthy individuals from racial/ethnic minority populations.
详细描述
The aim of this pilot study is to increase the number of healthy individuals from racial/ethnic minority populations. This will advance research being conducted at EMIC by providing "controls" or comparisons to differentiate between images from patients with cancer versus healthy people of the same racial/ethnic ancestry. In addition, blood samples from participants to this study will be utilized for quantitative, genetics-based estimates of ancestry (e.g., African, Chinese, Colombian, Western European, Mexican, Vietnamese, etc.), which is especially valuable in the case of admixed individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Men and women, 18 years of age or older
- •Member of a Federally recognized racial/ethnic minority population, e.g., African American or Black; Hispanic or Latino; Asian American; Native Hawaiian or Other Pacific Islander; Native American or Alaska Native
- •Willing and able to fast for at least 6 hours before and for the duration of the scan
- •Willing to provide urine samples throughout scan visit
- •Willing to provide blood samples for ancestry analysis
- •Willing and able to lay motionless in a supine position for up to 60 minutes and for up to 20 minutes at two separate timepoints
- •Willing and able to give informed consent, personal contact information (phone number, email and postal address), insurance information, and primary care physician contact
排除标准
- •No Primary Care Physician
- •No health insurance
- •Body weight more than 240 kg (529 pounds)
- •Any known concomitant acute infection (including upper respiratory infection, genitourinary infections, etc.)
- •History of metastatic or newly (last 5 years) diagnosed locally invasive cancer
- •Chemotherapy in the last 5 years
- •Radiation therapy in the last 3 years
- •Major surgery within the last 6 months
- •Pregnancy or breast-feeding
- •Fasting blood glucose level > 200 mg/dL before administration of fluorodeoxyglucose (FDG)
- •Prisoners
- •Self-reported history of dysphoria or anxiety in closed spaces
研究组 & 干预措施
EXPLORER PET/CT Imaging
Study participants will be injected with 10 +/- 2 mCi of 18F-FDG using and IV line and a 60 minute PET scan will begin on EXPLORER. Prior to the PET scan, an ultra-low-dose CT scan (less than 1 minute ) will be acquired for attenuation correction purposes only. Ninety (90) minutes after being injected with FDG, participants will have another ultra-low dose CT scan (less than 1 minute) which will be acquired for attenuation correction purposes only. This will be followed by a 20 minute PET scan on EXPLORER. One-hundred and twenty (120) minutes after being injected with FDG, participants will be positioned supine on the scanner table for the last time. At this time, a low dose CT scan (less than 1 minute) will be acquired once again for attenuation correction purposes. This will be followed by one last 20 minute PET scan on EXPLORER. The IV line will be removed after completion of the study.
干预措施: EXPLORER PET/CT (Device)
结局指标
主要结局
Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
时间窗: 3 hours
To collect preliminary data about total body FDG perfusion and early biodistribution in a cohort of racial/ethnic minority volunteers as measured by standardized uptake value (SUV) in gm/ml reported as Mean and Standard Deviation. The SUV is the ratio of the image-derived radioactivity concentration and the whole body concentration of the infected radioactivity.
Count of Participants With Confirmed Ancestry Informative Markers
时间窗: 15 minutes
Participants' self-reported racial/ethnic identity and ancestral origin confirmation with Ancestry Informative Markers (AIMS) analysis
次要结局
未报告次要终点