Clinical trial NCT04812080: EXPLORER PET/CT: Evaluation of Healthy Individuals From Racial/Ethnic Minority Populations
Official title: EXPLORER PET/CT: Evaluation of Healthy Individuals From Racial/Ethnic Minority Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers From Racial/Ethnic Minority Populations
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

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

Primary outcomes:
measure: Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
timeFrame: 3 hours
measure: Count of Participants With Confirmed Ancestry Informative Markers
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Moon Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: