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OpenTrials
Completed

NCT Number: NCT04812080

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.

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Key information

Conditions

Healthy Volunteers From Racial/Ethnic Minority Populations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EXPLORER PET/CT

Device

FDG PET Scans on the total body EXPLORER PET/CT scanner

Primary outcomes

  1. Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation

    Time frame: 3 hours

    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.

  2. Count of Participants With Confirmed Ancestry Informative Markers

    Time frame: 15 minutes

    Participants' self-reported racial/ethnic identity and ancestral origin confirmation with Ancestry Informative Markers (AIMS) analysis

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2021
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.