EXPLORER PET/CT in Healthy Volunteers

EXPLORER PET/CT: A Pilot Evaluation in Healthy Volunteers

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: EXPLORER PET/CT

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Diabetes
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: EXPLORER PET/CT; Intervention: PET/CT using different protocols
Other: 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.	Device: EXPLORER PET/CT; Intervention: PET/CT using different protocols
Other: 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.	Device: EXPLORER PET/CT; Intervention: PET/CT using different protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 BW= Body weight	To collect preliminary data regarding FDG biodistribution as a function of time. Time-activity curves will be created	approximatively 12 hours
Coefficient of variation. SD/mean (Standard deviation divided by mean value)	To obtain preliminary data regarding low dose EXPLORER noise level	approximatively 3 hours
Standardized Uptake Value	To collect preliminary data about total body FDG perfusion and early biodistribution. Time-activity curves will be created	approximatively 1 hour
Standardized Uptake Value SUV(t)= C(t)/(ID/BW) C(t) is radioactivity measured from an image 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 BW= Body weight	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.	approximatively 2 hours

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Lorenzo Nardo, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2019
• Primary Completion (Estimated): December 19, 2023
• Study Completion (Estimated): December 19, 2023

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1341792

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No