Characterization in 18F-FDG PET-CT of Brain and Lung Lesions in Subjects With a History of Severe COVID-19 (TEP-COV)

Central Hospital, Nancy, France

Status: Completed

Conditions: Covid-19

Treatments: Device: 18F-FDG PET-CT

Study type: Interventional

Funder types: Other

Identifiers

NCT04764721

A2021-01-01

Details and patient eligibility

About

Patients with Covid-19 (Coronavirus disease 19) may experience multiple neurological symptoms .

18F-FDG PET-CT ( Positons EmissionTomography coupled with a Computer Tomography with flurodesoxyglucose labelled with fluor 18), which reflects neuronal glycolytic metabolism, shows early variations in neuronal function.

Moreover the tropism of Covid-19 is essentially pulmonary and the hypothesis of this study is with 18F-FDG PET-CT it's possible to study the relationship between cerebral metabolism and the metabolism of pulmonary lesions following Covid-19 infection.

Full description

Patients with Covid-19 may experience multiple neurological symptoms including confusion and headaches (non-specific neurological symptoms), while others develop specific neurological manifestations, including stroke, related to increased bleeding disorders, seizures and signs of encephalitis.

The coronavirus enters the central nervous system through the olfactory bulb, causing olfactory and taste dysfunctions. These symptoms may appear before, during or even after the general symptoms.

Indeed, 18F-FDG PET-CT, which reflects neuronal glycolytic metabolism, shows early variations in neuronal function, even in the absence of morphological changes visualized by MRI (Magnetic Resonance Imaging).

Moreover the tropism of Covid-19 is essentially pulmonary and it is accepted that acute pulmonary lesions are independent risk factors for cerebral hypoxia. Furthermore, the cytokine storm due to COVID-19 and the resulting hyperinflammation state may induce a transient increase in pressure, with endothelial and vascular lesions and increased capillary permeability, and promote pulmonary oedema leading to secondary cerebral damage.

The lung/brain relationship is therefore essential to be studied in pathologies whose main tropism is the lung.

18F-FDG PET has the advantage of being able to explore both cerebral metabolism and the metabolism of COVID-19-related lung lesions.

The hypothesis of this study is that 18F-FDG PET-CT can objectify and characterize central nervous system involvement in Covid-19 infection. It also makes it possible to study the relationship between cerebral metabolism and the metabolism of pulmonary lesions following Covid-19 infection.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged between 18 and 65 years
• Patient included in the Neurocog-Covid study (i.e. presenting a cognitive disorder that has been objectified on the neuropsychological assessment and having to undergo a cerebral MRI),
• Patient who has received full information about the organization of the research and has given written informed consent (or a third person, independent of the investigator and sponsor, in the case of literacy disability),
• Patient affiliated to or beneficiary of a social security plan

Exclusion criteria

• Women of childbearing age who do not have effective contraception.
• Pregnant woman or nursing mother.
• Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code.
• Persons deprived of liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to articles L. 3212-1 and L. 3213-1
• Contraindication to perform 18F-FDG PET-CT
• Patients with a history of pre-Covid-19 psychiatric or chronic illness
• Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Patients enrolled in Neurocog-Covid study in Nancy hospital

Experimental group

Description:

Young patients (\< 65 year old) who contracted VIDOC 19 and were hospitalized for less than 7 days during the first wave, and who present cognitive disorders may be definitively included in the Neurocog-Covid study if their neuropsychological assessment is abnormal. They will then have a prescription for a cerebral MRI and will be enrolled in the TEP-Covid study. If they accept, they will receive a 18F-FDG PET-CT .

Treatment:

Device: 18F-FDG PET-CT