Clinical trial NCT04110743: EXPLORER PET/CT in Healthy Volunteers
Official title: EXPLORER PET/CT: A Pilot Evaluation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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, called EXPLORER.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: approximatively 12 hours for Arm 1 only
measure: Coefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)
timeFrame: approximatively 6 hours for Arm 1 only
measure: Standardized Uptake Value
timeFrame: approximatively 90 minutes
measure: 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
timeFrame: approximatively 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Lorenzo Nardo, MD
role: PRINCIPAL_INVESTIGATOR
References: