NCT05009563

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2022

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

August 16, 2021

Last Update Submit

August 16, 2021

Conditions

Coronavirus Infection

Keywords

COVID19PET-CTbrainlung

Outcome Measures

Primary Outcomes (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

    3 months

Secondary Outcomes (1)

  • total pulmonary metabolic inflammatory volume

    3 months

Other Outcomes (1)

  • cognitive status and quality of life

    3 months

Study Arms (2)

Inpatients with RT-PCR proven SARS-CoV-2 infection

EXPERIMENTAL

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

patients undergoing FDG-PET/CT for oncological indication

ACTIVE COMPARATOR

Age- and gender-matched group of patients undergoing FDG-PET/CT for oncological indication in the same time period

Radiation: FDG-PET/CT

Interventions

FDG-PET/CTRADIATION

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

Inpatients with RT-PCR proven SARS-CoV-2 infectionpatients undergoing FDG-PET/CT for oncological indication

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University Medical Imaging Centre

Budapest, Pest County, 1083, Hungary

RECRUITING

Related Publications (9)

  • 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.

    PMID: 32088847BACKGROUND

  • 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.

    PMID: 32142399BACKGROUND

  • 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.

    PMID: 32332319BACKGROUND

  • 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.

    PMID: 32936372BACKGROUND

  • 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.

    PMID: 32712702BACKGROUND

  • 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.

    PMID: 32728799BACKGROUND

  • 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.

    PMID: 32709734BACKGROUND

  • 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.

    PMID: 32410413BACKGROUND

  • 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.

    PMID: 32191587BACKGROUND

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pál Maurovich Horvat, MD PhD MPH

    Semmelweis University Medical Imaging Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pál Maurovich Horvat, MD PhD MPH

CONTACT

+361459-1500titkarsag.okk@med.semmelweis-univ.hu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 17, 2021

Study Start

January 4, 2021

Primary Completion

January 4, 2022

Study Completion

January 4, 2022

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations

HU(1)