Healthy Volunteers From Racial/Ethnic Minority Populations Clinical Trial
Official title:
EXPLORER PET/CT: Evaluation of Healthy Individuals From Racial/Ethnic Minority Populations
| Verified date | April 2023 |
| Source | University of California, Davis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | November 8, 2021 |
| Est. primary completion date | November 8, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of California, Davis | Sacramento | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Davis |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | To collect preliminary data about total body FDG perfusion and early biodistribution in a cohort of racial/ethnic minority volunteers as measured by standardized uptake value (SUV) in gm/ml reported as Mean and Standard Deviation. The SUV is the ratio of the image-derived radioactivity concentration and the whole body concentration of the infected radioactivity. | 3 hours | |
| Primary | Count of Participants With Confirmed Ancestry Informative Markers | Participants' self-reported racial/ethnic identity and ancestral origin confirmation with Ancestry Informative Markers (AIMS) analysis | 15 minutes |