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NCT04841707 Clinical Trial

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

Covid19 Clinical Trial

Official title:
Total-Body Parametric 18F-FDG PET of COVID-19

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04841707
Other study ID # 1697954
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2021
Est. completion date July 6, 2022

Study information
Verified date December 2022
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date July 6, 2022
Est. primary completion date July 6, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of California, Davis Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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