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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers From Racial/Ethnic Minority Populations
• Intervention / Treatment: Device: EXPLORER PET/CT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EXPLORER PET/CT Imaging; 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; FDG PET Scans on the total body EXPLORER PET/CT scanner

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Moon Chen, PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): November 8, 2021
• Study Completion (Actual): November 8, 2021

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1714742

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No