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

Primary Purpose

Covid-19

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
18F-FDG PET-CT
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid-19 focused on measuring Covid-19, brain, 18F-FDG PET-CT, lung

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHRU NANCY Brabois, nuclear medicine departmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients enrolled in Neurocog-Covid study in Nancy hospital

Arm 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 .

Outcomes

Primary Outcome Measures

To characterize the changes in brain metabolism in 18F-FDG PET-CT in patients enrolled in Neurocog-Study in the hospital of Nancy
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

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
Number of abnormal MRI and number of abnormal 18F-FDG PET-CT
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
Volumes and topographies of brain with a decrease in glycolytic metabolism in 18F-FDG PET-CT in relation to cognitive profiles identified as deficient.
Correlating brain metabolism to the volume of damage to the lung sequelae of Covid-19.
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

Full Information

First Posted
February 19, 2021
Last Updated
August 23, 2022
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT04764721
Brief Title
Characterization in 18F-FDG PET-CT of Brain and Lung Lesions in Subjects With a History of Severe COVID-19
Acronym
TEP-COV
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
Covid-19, brain, 18F-FDG PET-CT, lung

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with sequential psycho-cognitive disorders following severe COVID-19 and included in the Neurocog-Covid study
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients enrolled in Neurocog-Covid study in Nancy hospital
Arm Type
Experimental
Arm 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 .
Intervention Type
Device
Intervention Name(s)
18F-FDG PET-CT
Intervention Description
Enrolled patients in Neurocog-Covid will receive a 18F-FDG PET-CT
Primary Outcome Measure Information:
Title
To characterize the changes in brain metabolism in 18F-FDG PET-CT in patients enrolled in Neurocog-Study in the hospital of Nancy
Description
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.
Time Frame
13 months
Secondary Outcome Measure Information:
Title
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
Description
Number of abnormal MRI and number of abnormal 18F-FDG PET-CT
Time Frame
13 months
Title
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
Description
Volumes and topographies of brain with a decrease in glycolytic metabolism in 18F-FDG PET-CT in relation to cognitive profiles identified as deficient.
Time Frame
13 months
Title
Correlating brain metabolism to the volume of damage to the lung sequelae of Covid-19.
Description
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
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine VERGER, MD, PhD
Phone
038315567
Ext
+33
Email
a.verger@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique ROCH, MSc
Phone
03 83 15 42 76
Ext
+33
Email
v.roch@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine VERGER, MD, PhD
Organizational Affiliation
CHRU Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU NANCY Brabois, nuclear medicine department
City
Vandoeuvre les Nancy cedex
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Mr VERGER, MD,PhD
Phone
383154276
Ext
+33
Email
a.verger@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Véronique Mrs ROCH, MsC
Phone
383154276
Ext
+33
Email
v.roch@chru-nancy.fr

12. IPD Sharing Statement

Learn more about this trial

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

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