COvid iMaging With POSitron Emission Tomography (COMPOSIT)

August 16, 2021 updated by: Semmelweis University Heart and Vascular Center

Evaluation of COVID-19 by Whole-body FDG-PET/CT

We aim to study if metabolic intensity and extent according to pathologic pulmonary 18F-2-fluoro-2-deoxy-D-glucose (FDG)-uptake may correlate with the course of COVID-19 pneumonia and potentially yield prognostic value. Moreover, we aim to assess permanent changes after Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, such as pulmonary fibrosis and neuropsychiatric symptoms (anosmia, depression, fatigue) where evaluation with FDG-positron emission tomography (PET/CT) might have an impact on further patient care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Several case studies confirmed increased FDG-uptake on PET scans corresponding to typical pulmonary lesions on chest CT scans in patients with COVID-19 pneumonia. Furthermore, increased FDG-uptake most likely caused by inflammatory changes in SARS-CoV-2 infection were described in other organs, such as mediastinal lymph nodes, bone marrow, and the spleen. As COVID-19 frequently presents with anosmia and on rare occasions, symptoms of encephalitis, metabolic changes in the central nervous system (CNS) were also investigated by FDG-PET/CT, showing hypometabolism in the olfactory gyrus and the limbic system, while hypermetabolism was observed in the basal ganglia and the cerebellar vermis. Late changes in pulmonary CT-morphology, most commonly interstitial thickening and crazy paving are observed, suggesting permanent lung damage after SARS-CoV-2 infection in certain cases. Evaluation of metabolic activity of acute and late inflammatory changes could potentially provide clinical benefit as dedicated medication could be started to prevent further organ damage due to prolonged inflammation.

We aim to evaluate metabolic alterations in the lung parenchyma and potential extrapulmonary locations related to to COVID-19 with FDG-PET/CT.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
    • Pest
      • Budapest, Pest, Hungary, 1083

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inpatients with RT-PCR proven SARS-CoV-2 infection of the Department of Pulmonology of Semmelweis University

Exclusion Criteria:

  • Age<40 years for men and <45 years for women
  • Pregnancy
  • Clinically unstable patients
  • Patients in need of mechanical ventilation support
  • Patients with known malignant disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inpatients with RT-PCR proven SARS-CoV-2 infection
Inpatients with real-time reverse-transcriptase polymerase chain reaction (RT-PCR) proven SARS-CoV-2 infection of the Department of Pulmonology of Semmelweis University who will undergo whole-body FDG-PET/CT
Radiation: FDG-PET/CT
whole-body F-18-fluoro-deoxy-glucose positron emission tomography/computed tomography
Active Comparator: patients undergoing FDG-PET/CT for oncological indication
Age- and gender-matched group of patients undergoing FDG-PET/CT for oncological indication in the same time period
Radiation: FDG-PET/CT
whole-body F-18-fluoro-deoxy-glucose positron emission tomography/computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
extrapulmonary increased FDG-uptake
Time Frame: 3 months
observation of sites with extrapulmonary hypermetabolic foci in possible conjunction with COVID-19 and brain metabolic changes, with follow-up scan
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total pulmonary metabolic inflammatory volume
Time Frame: 3 months
measurement of metabolic activity of COVID-19 pneumonia and changes on follow-up scan
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive status and quality of life
Time Frame: 3 months
investigation of possible COVID-19-related cognitive changes and impact on quality of life, with follow-up
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University Heart and Vascular Center

Collaborators

Semmelweis University Department of Pulmonology
Semmelweis University Medical Imaging Centre

Investigators

  • Principal Investigator: Pál Maurovich Horvat, MD PhD MPH, Semmelweis University Medical Imaging Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2021

Primary Completion (Anticipated)

January 4, 2022

Study Completion (Anticipated)

January 4, 2022

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMPOSIT Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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