Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04764721
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2021-02-19
Brief Title:
Characterization in 18F-FDG PET-CT of Brain and Lung Lesions in Subjects With a History of Severe COVID-19
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Characterization in 18F-FDG PET-CT of Brain and Lung Lesions in Young Subjects With Sequelae Psycho-cognitive Disorders in the Aftermath of Severe Covid-19
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEP-COV
Brief Summary:
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 its possible to study the relationship between cerebral metabolism and the metabolism of pulmonary lesions following Covid-19 infection
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 its possible to study the relationship between cerebral metabolism and the metabolism of pulmonary lesions following Covid-19 infection
Detailed 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 lungbrain 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
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 lungbrain 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None