COvid iMaging With POSitron Emission Tomography

Coronavirus Infection Clinical Trial

— COMPOSIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05009563
• Other study ID #: COMPOSIT Study
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: January 4, 2022

Study information

• Verified date: August 2021
• Source: Semmelweis University Heart and Vascular Center
• Contact: Pál Maurovich Horvat, MD PhD MPH
• Phone: +361459-1500
• Email: titkarsag.okk[@]med.semmelweis-univ.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 4, 2022
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections

Intervention

Radiation:
• FDG-PET/CT
whole-body F-18-fluoro-deoxy-glucose positron emission tomography/computed tomography

Locations

Country	Name	City	State
Hungary	Semmelweis University Medical Imaging Centre	Budapest	Pest

Sponsors (3)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center	Semmelweis University Department of Pulmonology, Semmelweis University Medical Imaging Centre

Country where clinical trial is conducted

Hungary, 

References & Publications (9)

Cabrera Villegas A, Romero Robles LG, Boulvard Chollet XLE, Albornoz Almada MC, Mangas Losada M, Garrastachu P, Cañete Sánchez FM, Ramírez Lasanta R, Delgado Bolton RC. [(18)F]-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. — View 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. — View Citation

Grimaldi S, Lagarde S, Harlé JR, Boucraut J, Guedj E. Autoimmune Encephalitis Concomitant with SARS-CoV-2 Infection: Insight from (18)F-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. — View Citation

Guedj E, Million M, Dudouet P, Tissot-Dupont H, Bregeon F, Cammilleri S, Raoult D. (18)F-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. — View 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. — View Citation

Qin C, Liu F, Yen TC, Lan X. (18)F-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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cognitive status and quality of life	investigation of possible COVID-19-related cognitive changes and impact on quality of life, with follow-up	3 months
Primary	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	total pulmonary metabolic inflammatory volume	measurement of metabolic activity of COVID-19 pneumonia and changes on follow-up scan	3 months