EXPLORER PET/CT: A Pilot Evaluation in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Standardized Uptake Value SUV(t)= C(t)/ID/BW; C(t) is Radioactivity Measured at the Time t, Decay Corrected to t=0 and Converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; W= Body Weight; SUV is Correct UM
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Willing and able to fast for at least 6 hours before and for the duration of the scan
- •Willing and able to lay motionless in a supine position for 60 and 20 minutes at separate timepoints.
- •Willing and able to give informed consent
排除标准
- •No Primary Care Physician
- •Body weight >240 kg
- •Allergy to iodine contrast (only for subjects enrolled in Arm 3)
- •Creatinine levels > 1.5 mg/dL or estimated glomerular filtration rate (eGFR) < 60 ml/minute (only for subjects enrolled in Arm 3)
- •Recent (1 month) contrast enhanced CT
- •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 > 160 mg/dL before administration of FDG
- •Prisoners
- •The standard MRI contraindications apply, including but not limited to:
- •Having a pacemaker or other implanted electronic device. Metal foreign bodies, aneurysm clips, heart valve prosthesis, vascular stents, cochlear implants, embolization coils, gunshot wounds with retained bullet fragments, penile implant, IUCD.
- •Claustrophobia
结局指标
主要结局
Standardized Uptake Value SUV(t)= C(t)/ID/BW; C(t) is Radioactivity Measured at the Time t, Decay Corrected to t=0 and Converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; W= Body Weight; SUV is Correct UM
时间窗: approximatively 12 hours for Arm 1 only
To collect preliminary data regarding FDG biodistribution in the organs listed as a function of time of 12 hours. Time-activity curves will be created
Coefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)
时间窗: approximatively 6 hours for Arm 1 only
To obtain preliminary data regarding low dose EXPLORER noise level
Standardized Uptake Value
时间窗: approximatively 90 minutes
To collect preliminary data about total body FDG perfusion and early biodistribution. Time-activity curves will be created
Standardized Uptake Value SUV(t)= C(t)/(ID/BW); C(t) is Radioactivity Measured From at Time t, Decay Corrected to t=0-converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; BW= Body Weight; SUV is Correct UM
时间窗: approximatively 3 hours
To obtain preliminary data to understand whether intravenous iodinated contrast agent produce a significant change in quantification of FDG uptake levels. Time/activity curves will be generated.
次要结局
未报告次要终点