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

• Sponsor: University of California, Davis (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04841707
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 33.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Device: uEXPLORER/mCT	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Total-Body Parametric 18F-FDG PET of COVID-19
• Actual Study Start Date: May 10, 2021
• Anticipated Primary Completion Date: Feb 22, 2023
• Anticipated Study Completion Date: Feb 22, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. BAB permeability assessed [1 imaging visit up to 60 minutes]

   Evaluating if there is a change in BAB permeability assessed by lung FDG K1 for patients with COVID 19

Secondary Outcome Measures

1. 4 month follow-up PET/CT scan [1 imaging visit up to 60 minutes]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Davis	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Learn more or sign up for the study here!

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT04841707
• Other Study ID Numbers: 1697954
• First Posted: Apr 12, 2021
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Aug 5, 2022