Total-Body Parametric 18F-FDG PET of COVID-19

The primary objective is to measure the change between COVID-19 patients and normal subjects; the secondary objective is to measure the change in COVID-19 patients between baseline and 4-month follow up.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Device: uEXPLORER/mCT

• Study Type: Interventional
• Enrollment (Actual): 13
• 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: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• COVID-19 positive patients will have a previous positive COVID-19 test and radiographic findings, and/or a positive SARS-CoV-2 antibody test and be in early recovery.
• First PET/CT visit needs to be within 8 weeks of COVID-19 diagnosis.
• Ability to understand and willingness to sign an informed consent form.
• Ability to adhere to the study visit schedule and other protocol requirements.
• All persons ≥18 years of age.

Exclusion Criteria:

• Pregnant or lactating women.
• Any condition that would prohibit the understanding or rendering of informed consent.
• Unable to lie supine for 1-hour imaging with PET.
• Prisoners.
• Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• 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: COVID-19 patients	Device: uEXPLORER/mCT; Each participant will undergo two 18F-FDG PET/CT scans, one at baseline and one at 4- month (+/- 2 weeks) follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BAB permeability assessed	Evaluating if there is a change in BAB permeability assessed by lung FDG K1 for patients with COVID 19	1 imaging visit up to 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
4 month follow-up PET/CT scan	Evaluate the change in the scans between baseline scan and 4-month follow-up scan by assessing the pulmonary blood-air barrier permeability to glucose	1 imaging visit up to 60 minutes

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Guobao Wang, PhD, University of California, Davis

Publications and helpful links

Helpful Links

• Learn more or sign up for the study here!

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): July 6, 2022
• Study Completion (Actual): July 6, 2022

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: 1697954

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