N/A
Completed N=30
EXPLORER PET/CT in Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT04110743 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: 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 — 0.83; 0.48; 1.68; 2.01 SUV
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0.83; 0.48; 1.68; 2.01; 1.91; 3.44 | — |
| PRIMARY Coefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value) |
60.5; 140.1; 32.2; 31.4; 64.4; 40.8 | — |
| PRIMARY Standardized Uptake Value |
1.75; 0.88; 0.62; 0.32; 2.49; 1.02 | — |
| PRIMARY 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 |
1.18; 0.39; 0.52; 0.15; 2.11; 0.50 | — |
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) 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
Data sourced from ClinicalTrials.gov (NCT04110743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.