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

NCT ID: NCT04841707

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2022-07-06

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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COVID-19 patients

Group Type EXPERIMENTAL

uEXPLORER/mCT

Intervention Type DEVICE

Each participant will undergo two 18F-FDG PET/CT scans, one at baseline and one at 4- month (+/- 2 weeks) follow-up.

Interventions

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uEXPLORER/mCT

Each participant will undergo two 18F-FDG PET/CT scans, one at baseline and one at 4- month (+/- 2 weeks) follow-up.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guobao Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California, Davis

Sacramento, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1697954

Identifier Type: -

Identifier Source: org_study_id