TEP-COV: 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 (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04764721
Collaborator
(none)
50
Enrollment
1
Arm
7
Anticipated Duration (Months)

Study Details

Study Description

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 it's possible to study the relationship between cerebral metabolism and the metabolism of pulmonary lesions following Covid-19 infection.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: 18F-FDG PET-CT
N/A

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patients with sequential psycho-cognitive disorders following severe COVID-19 and included in the Neurocog-Covid studyPatients with sequential psycho-cognitive disorders following severe COVID-19 and included in the Neurocog-Covid study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Anticipated Study Start Date :
Oct 12, 2021
Anticipated Primary Completion Date :
Apr 12, 2022
Anticipated Study Completion Date :
May 12, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Patients enrolled in Neurocog-Covid study in Nancy hospital

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 .

Device: 18F-FDG PET-CT
Enrolled patients in Neurocog-Covid will receive a 18F-FDG PET-CT

Outcome Measures

Primary Outcome Measures

  1. To characterize the changes in brain metabolism in 18F-FDG PET-CT in patients enrolled in Neurocog-Study in the hospital of Nancy [13 months]

    Volumes and topographies of brain with a decrease in glycolytic metabolism in 18F-FDG PET-CT compared to the brain metabolism of a control population.

Secondary Outcome Measures

  1. To compare the sensitivity of detection of cerebral abnormalities in MRI and 18F-FDG PET-CT in patients included in Neurocog-Covid study at the hospital of Nancy [13 months]

    Number of abnormal MRI and number of abnormal 18F-FDG PET-CT

  2. To correlate the brain functions impacted on the neuropsychological assessment to the brain metabolism in 18F-FDG PET-CT in patients included in the Neurocog-Covid study at the Nancy Hospital [13 months]

    Volumes and topographies of brain with a decrease in glycolytic metabolism in 18F-FDG PET-CT in relation to cognitive profiles identified as deficient.

  3. Correlating brain metabolism to the volume of damage to the lung sequelae of Covid-19. [13 months]

    Volumes and topographies of brain with a decrease in glycolytic metabolism in 18F-FDG PET-CT in relation to the volumes affected in the lungs

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT04764721
Other Study ID Numbers:
  • A2021-01-01
First Posted:
Feb 21, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021