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
- 1
- 主要终点
- Standardized Uptake Value
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
研究组 & 干预措施
comparison PET images reconstructed using CT-based attenuation
10 mCi of 18F-FDG will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. Prior to the dynamic scan, an ultra-low-dose CT scan (1.298 mSv) will be acquired for attenuation correction purposes only. At 90 mins, a low dose non contrast enhancement CT (7.44 mSv) will be acquired vertex to toes. Iodinated contrast (150 cc of iodine Omnipaque 350) will then be intravenously injected (through the same IV placed to inject FDG) at 3 ml/sec while the patient remains still on the scanner and a second low-dose CT will be acquired. Finally, a 20-minute PET acquisition will be performed. The IV line will be removed after completion of the study. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation.
干预措施: EXPLORER PET/CT (Device)
delayed imaging acquisition
10 mCi of 18F fluorodeoxyglucose (FDG) will be injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The IV line will be removed after dynamic acquisition. The dynamic scan will be preceded by ultra low-dose (1.298 mSv) CT scan to provide information for attenuation correction for the PET data. At 90 minutes, 3-, 6-, 9- and 12-hours, a static whole-body scan for 20 minutes will be acquired on EXPLORER. Prior to the 90-minute scan a low-dose CT (7.44 mSv) will be obtained both for anatomic localization and for attenuation correction purposes. Prior to each of the later time-points (3-, 6-, 9- and 12-hours), an ultra low-dose (1.298 mSv) CT scan will be acquired. This scan will be for attenuation correction purposes only. Following the 12-hour scan, the participant's study visit will be completed. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation.
干预措施: EXPLORER PET/CT (Device)
low FDG dose imaging
0.5 mCi of 18F-FDG (1/20th of the standard dose) will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The dynamic scan will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction. The standard 20-minute EXPLORER scan obtained at 90 minutes will be obtained after a low dose CT (7.44 mSv) for attenuation and co-localization. The standard 20-minute EXPLORER scan obtained at 3 hours will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction only. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation.
干预措施: EXPLORER PET/CT (Device)
结局指标
主要结局
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 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 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