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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04841707
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : June 4, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : February 22, 2022
Estimated Study Completion Date : February 22, 2023

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.




Primary Outcome Measures :
  1. BAB permeability assessed [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04841707


Contacts
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Contact: Lynda Painting 916-731-9004 lpainting@ucdavis.edu
Contact: Dana Little, MS 916-734-7749 dalittle@ucdavis.edu

Locations
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United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Lynda Painting, BS    916-731-9004    lpainting@ucdavis.edu   
Contact: Dana Little, MS    916-734-7749    dalittle@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Guobao Wang, PhD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04841707    
Other Study ID Numbers: 1697954
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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