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COvid iMaging With POSitron Emission Tomography (COMPOSIT)

S

Semmelweis University

Status

Unknown

Conditions

Coronavirus Infection

Treatments

Radiation: FDG-PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT05009563
COMPOSIT Study

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Inpatients with RT-PCR proven SARS-CoV-2 infection
Experimental group
Description:
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
Treatment:
Radiation: FDG-PET/CT
patients undergoing FDG-PET/CT for oncological indication
Active Comparator group
Description:
Age- and gender-matched group of patients undergoing FDG-PET/CT for oncological indication in the same time period
Treatment:
Radiation: FDG-PET/CT

Trial contacts and locations

1

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Central trial contact

Pál Maurovich Horvat, MD PhD MPH

Data sourced from clinicaltrials.gov

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