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

Not Applicable

Completed

• Conditions: Healthy Volunteers From Racial/Ethnic Minority Populations
• Interventions: Device: EXPLORER PET/CT

• Registration Number: NCT04812080
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Study Start: 2021-08-18
• Primary Completion: 2021-11-08
• Study Completion: 2021-11-08
• Results First Submitted: 2022-10-27
• Results First Submitted QC: 2023-02-13
• Results First Posted: 2023-02-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EXPLORER PET/CT Imaging	EXPLORER PET/CT	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.

Primary Outcome Measures

Name	Time	Method
Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation	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.
Count of Participants With Confirmed Ancestry Informative Markers	15 minutes	Participants' self-reported racial/ethnic identity and ancestral origin confirmation with Ancestry Informative Markers (AIMS) analysis

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Sacramento, California, United States