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

NCT04812080 | Completed Results

• 1 other identifier: 1714742
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers From Racial/Ethnic Minority Populations

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

EXPLORER PET/CT Imaging

EXPERIMENTAL

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

Interventions

EXPLORER PET/CT DEVICE

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

EXPLORER PET/CT Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Results Point of Contact

• Title: Dr. Moon Chen
• Organization: University of California Davis

mschenjr@ucdavis.edu

916-734-1191

Study Officials

• Moon Chen, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: August 18, 2021
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: March 11, 2026
• Results First Posted: February 15, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)