EXPLORER PET/CT: Evaluation of Healthy Individuals From Racial/Ethnic Minority Populations

Study Overview
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Brief Summary
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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.

Detailed Description
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The aim of this pilot study is to increase the number of healthy individuals from racial/ethnic minority populations. This will advance research being conducted at EMIC by providing controls or comparisons to differentiate between images from patients with cancer versus healthy people of the same racial/ethnic ancestry. In addition, blood samples from participants to this study will be utilized for quantitative, genetics-based estimates of ancestry (e.g., African, Chinese, Colombian, Western European, Mexican, Vietnamese, etc.), which is especially valuable in the case of admixed individuals.

Official Title
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EXPLORER PET/CT: Evaluation of Healthy Individuals From Racial/Ethnic Minority Populations

Conditions
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Healthy Volunteers From Racial/Ethnic Minority Populations

Intervention / Treatment
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* Device: EXPLORER PET/CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPLORER PET/CT Imaging<br>Study participants will be injected with 10 +/- 2 mCi of 18F-FDG using and IV line and a 60 minute PET scan will begin on EXPLORER. Prior to the PET scan, an ultra-low-dose CT scan (less than 1 minute ) will be acquired for attenuation correction purposes only. Ninety (90) minutes after being injected with FDG, participants will have another ultra-low dose CT scan (less than 1 minute) which will be acquired for attenuation correction purposes only. This will be followed by a 20 minute PET scan on EXPLORER. One-hundred and twenty (120) minutes after being injected with FDG, participants will be positioned supine on the scanner table for the last time. At this time, a low dose CT scan (less than 1 minute) will be acquired once again for attenuation correction purposes. This will be followed by one last 20 minute PET scan on EXPLORER. The IV line will be removed after completion of the study. | Device: EXPLORER PET/CT<br>* FDG PET Scans on the total body EXPLORER PET/CT scanner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |