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Coronavirus InfectionCOMPOSITNCT05009563

COvid iMaging With POSitron Emission Tomography

A study testing FDG-PET/CT in people with Coronavirus Infection, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Coronavirus Infection
What is being tested?
FDG-PET/CT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteHungary
Study dates
4 Jan 2021to 4 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Pál Maurovich Horvat, MD PhD MPH contact

+361459-1500 ext. 61812

titkarsag.okk@med.semmelweis-univ.hu

Hungary1 site, 1 recruiting

  • Semmelweis University Medical Imaging Centre

    Budapest, Pest County, 1083

    Pál Maurovich Horvat, MD PhD MPH, +361459-1500 ext. 61812, okk.titkarsag@med.semmelweis-univ.hu

    Recruiting

Other trials in Hungary

About this study

Official title: 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.

Read the 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.

Being tested
FDG-PET/CT
Keywords
COVID19, PET-CT, brain, lung
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FDG-PET/CTRadiation

    whole-body F-18-fluoro-deoxy-glucose positron emission tomography/computed tomography

Study groups in NCT05009563
Study groupRoleWhat they receive
Inpatients with RT-PCR proven SARS-CoV-2 infectionExperimentalInpatients 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
Receives: Radiation: FDG-PET/CT
patients undergoing FDG-PET/CT for oncological indicationActive comparatorAge- and gender-matched group of patients undergoing FDG-PET/CT for oncological indication in the same time period
Receives: Radiation: FDG-PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. extrapulmonary increased FDG-uptake

    observation of sites with extrapulmonary hypermetabolic foci in possible conjunction with COVID-19 and brain metabolic changes, with follow-up scan

    Measured: 3 months

Secondary outcomes (1)

  1. total pulmonary metabolic inflammatory volume

    measurement of metabolic activity of COVID-19 pneumonia and changes on follow-up scan

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2021
  2. Study start4 Jan 2021
  3. Primary completion4 Jan 2022 (estimated)
  4. Study completion4 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05009563
Sponsor's protocol ID
COMPOSIT Study
Acronym
COMPOSIT
Status last verified
Aug 2021
First submitted
16 Aug 2021
Last updated
17 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Qin C, Liu F, Yen TC, Lan X. 18F-FDG PET/CT findings of COVID-19: a series of four highly suspected cases. Eur J Nucl Med Mol Imaging. 2020 May;47(5):1281-1286. doi: 10.1007/s00259-020-04734-w. Epub 2020 Feb 22.

    PubMed 32088847

  • Zou S, Zhu X. FDG PET/CT of COVID-19. Radiology. 2020 Aug;296(2):E118. doi: 10.1148/radiol.2020200770. Epub 2020 Mar 6. No abstract available.

    PubMed 32142399

  • Liu C, Zhou J, Xia L, Cheng X, Lu D. 18F-FDG PET/CT and Serial Chest CT Findings in a COVID-19 Patient With Dynamic Clinical Characteristics in Different Period. Clin Nucl Med. 2020 Jun;45(6):495-496. doi: 10.1097/RLU.0000000000003068.

    PubMed 32332319

  • Cabrera Villegas A, Romero Robles LG, Boulvard Chollet XLE, Albornoz Almada MC, Mangas Losada M, Garrastachu P, Canete Sanchez FM, Ramirez Lasanta R, Delgado Bolton RC. [18F]-FDG PET/CT in oncologic patients with unsuspected asymptomatic infection with SARS-CoV-2. Eur J Nucl Med Mol Imaging. 2021 Mar;48(3):786-793. doi: 10.1007/s00259-020-04979-5. Epub 2020 Sep 16.

    PubMed 32936372

  • Dietz M, Chironi G, Claessens YE, Farhad RL, Rouquette I, Serrano B, Nataf V, Hugonnet F, Paulmier B, Berthier F, Keita-Perse O, Giammarile F, Perrin C, Faraggi M; MONACOVID Group. COVID-19 pneumonia: relationship between inflammation assessed by whole-body FDG PET/CT and short-term clinical outcome. Eur J Nucl Med Mol Imaging. 2021 Jan;48(1):260-268. doi: 10.1007/s00259-020-04968-8. Epub 2020 Jul 25.

    PubMed 32712702

  • Guedj E, Million M, Dudouet P, Tissot-Dupont H, Bregeon F, Cammilleri S, Raoult D. 18F-FDG brain PET hypometabolism in post-SARS-CoV-2 infection: substrate for persistent/delayed disorders? Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):592-595. doi: 10.1007/s00259-020-04973-x. Epub 2020 Jul 30.

    PubMed 32728799

  • Grimaldi S, Lagarde S, Harle JR, Boucraut J, Guedj E. Autoimmune Encephalitis Concomitant with SARS-CoV-2 Infection: Insight from 18F-FDG PET Imaging and Neuronal Autoantibodies. J Nucl Med. 2020 Dec;61(12):1726-1729. doi: 10.2967/jnumed.120.249292. Epub 2020 Jul 24.

    PubMed 32709734

  • Yu M, Liu Y, Xu D, Zhang R, Lan L, Xu H. Prediction of the Development of Pulmonary Fibrosis Using Serial Thin-Section CT and Clinical Features in Patients Discharged after Treatment for COVID-19 Pneumonia. Korean J Radiol. 2020 Jun;21(6):746-755. doi: 10.3348/kjr.2020.0215.

    PubMed 32410413

  • Wang Y, Dong C, Hu Y, Li C, Ren Q, Zhang X, Shi H, Zhou M. Temporal Changes of CT Findings in 90 Patients with COVID-19 Pneumonia: A Longitudinal Study. Radiology. 2020 Aug;296(2):E55-E64. doi: 10.1148/radiol.2020200843. Epub 2020 Mar 19.

    PubMed 32191587

Questions about this trial

What is this clinical trial studying?

A study testing FDG-PET/CT in people with Coronavirus Infection, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pál Maurovich Horvat, MD PhD MPH (+361459-1500 ext. 61812, titkarsag.okk@med.semmelweis-univ.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

extrapulmonary increased FDG-uptake (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05009563, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.

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