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COvid iMaging With POSitron Emission Tomography (COMPOSIT)

Primary Purpose

Coronavirus Infection

Status
Unknown status
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
FDG-PET/CT
Sponsored by
Semmelweis University Heart and Vascular Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronavirus Infection focused on measuring COVID19, PET-CT, brain, lung

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Semmelweis University Medical Imaging CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

patients undergoing FDG-PET/CT for oncological indication

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

total pulmonary metabolic inflammatory volume
measurement of metabolic activity of COVID-19 pneumonia and changes on follow-up scan

Full Information

First Posted
August 16, 2021
Last Updated
August 16, 2021
Sponsor
Semmelweis University Heart and Vascular Center
Collaborators
Semmelweis University Department of Pulmonology, Semmelweis University Medical Imaging Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05009563
Brief Title
COvid iMaging With POSitron Emission Tomography
Acronym
COMPOSIT
Official Title
Evaluation of COVID-19 by Whole-body FDG-PET/CT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
January 4, 2022 (Anticipated)
Study Completion Date
January 4, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Semmelweis University Heart and Vascular Center
Collaborators
Semmelweis University Department of Pulmonology, Semmelweis University Medical Imaging Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection
Keywords
COVID19, PET-CT, brain, lung

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inpatients with RT-PCR proven SARS-CoV-2 infection
Arm Type
Experimental
Arm 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
Arm Title
patients undergoing FDG-PET/CT for oncological indication
Arm Type
Active Comparator
Arm Description
Age- and gender-matched group of patients undergoing FDG-PET/CT for oncological indication in the same time period
Intervention Type
Radiation
Intervention Name(s)
FDG-PET/CT
Intervention Description
whole-body F-18-fluoro-deoxy-glucose positron emission tomography/computed tomography
Primary Outcome Measure Information:
Title
extrapulmonary increased FDG-uptake
Description
observation of sites with extrapulmonary hypermetabolic foci in possible conjunction with COVID-19 and brain metabolic changes, with follow-up scan
Time Frame
3 months
Secondary Outcome Measure Information:
Title
total pulmonary metabolic inflammatory volume
Description
measurement of metabolic activity of COVID-19 pneumonia and changes on follow-up scan
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
cognitive status and quality of life
Description
investigation of possible COVID-19-related cognitive changes and impact on quality of life, with follow-up
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pál Maurovich Horvat, MD PhD MPH
Phone
+361459-1500
Ext
61812
Email
titkarsag.okk@med.semmelweis-univ.hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pál Maurovich Horvat, MD PhD MPH
Organizational Affiliation
Semmelweis University Medical Imaging Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semmelweis University Medical Imaging Centre
City
Budapest
State/Province
Pest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pál Maurovich Horvat, MD PhD MPH
Phone
+361459-1500
Ext
61812
Email
okk.titkarsag@med.semmelweis-univ.hu

12. IPD Sharing Statement

Citations:
PubMed Identifier
32088847
Citation
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.
Results Reference
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PubMed Identifier
32142399
Citation
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.
Results Reference
background
PubMed Identifier
32332319
Citation
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.
Results Reference
background
PubMed Identifier
32936372
Citation
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.
Results Reference
background
PubMed Identifier
32712702
Citation
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.
Results Reference
background
PubMed Identifier
32728799
Citation
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.
Results Reference
background
PubMed Identifier
32709734
Citation
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.
Results Reference
background
PubMed Identifier
32410413
Citation
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.
Results Reference
background
PubMed Identifier
32191587
Citation
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.
Results Reference
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COvid iMaging With POSitron Emission Tomography

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