N/A
Completed N=20
EXPLORER PET/CT: Evaluation of Healthy Individuals From Racial/Ethnic Minority Populations
Healthy Volunteers From Racial/Ethnic Minority Populations
Source: ClinicalTrials.gov NCT04812080 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation — 7.293; 5.157; 4.429; 2.357 gm/ml
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. The study will aim to recruit healthy individuals from racial/ethnic minority populations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation |
7.293; 5.157; 4.429; 2.357; 1.039; 0.794 | — |
| PRIMARY Count of Participants With Confirmed Ancestry Informative Markers |
20 | — |
Eligibility Criteria
Inclusion criteria
- Men and women, 18 years of age or older
- Member of a Federally recognized racial/ethnic minority population, e.g., African American or Black; Hispanic or Latino; Asian American; Native Hawaiian or Other Pacific Islander; Native American or Alaska Native
- Willing and able to fast for at least 6 hours before and for the duration of the scan
- Willing to provide urine samples throughout scan visit
- Willing to provide blood samples for ancestry analysis
- Willing and able to lay motionless in a supine position for up to 60 minutes and for up to 20 minutes at two separate timepoints
- Willing and able to give informed consent, personal contact information (phone number, email and postal address), insurance information, and primary care physician contact
Exclusion criteria
- No Primary Care Physician
- No health insurance
- Body weight more than 240 kg (529 pounds)
- 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 > 200 mg/dL before administration of fluorodeoxyglucose (FDG)
- Prisoners
- Self-reported history of dysphoria or anxiety in closed spaces
Data sourced from ClinicalTrials.gov (NCT04812080). 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.