Status:
COMPLETED
EXPLORER PET/CT in Healthy Volunteers
Lead Sponsor:
University of California, Davis
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04110743
Start Date
June 19 2019
End Date
February 6 2020
Last Update
November 21 2024
Active Locations (1)
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1
University of California, Davis
Sacramento, California, United States, 95817