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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
uEXPLORER/mCT
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Davis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COVID-19 patients

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 31, 2021
Last Updated
December 14, 2022
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT04841707
Brief Title
Total-Body Parametric 18F-FDG PET of COVID-19
Official Title
Total-Body Parametric 18F-FDG PET of COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
July 6, 2022 (Actual)
Study Completion Date
July 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
uEXPLORER/mCT
Intervention Description
Each participant will undergo two 18F-FDG PET/CT scans, one at baseline and one at 4- month (+/- 2 weeks) follow-up.
Primary Outcome Measure Information:
Title
BAB permeability assessed
Description
Evaluating if there is a change in BAB permeability assessed by lung FDG K1 for patients with COVID 19
Time Frame
1 imaging visit up to 60 minutes
Secondary Outcome Measure Information:
Title
4 month follow-up PET/CT scan
Description
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
Time Frame
1 imaging visit up to 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guobao Wang, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://studypages.com/s/total-body-parametric-18f-fdg-pet-of-covid-19-612590/
Description
Learn more or sign up for the study here!

Learn more about this trial

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

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