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

NCT04764721 | Completed

• 1 other identifier: A2021-01-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19

Keywords

Covid-19; brain; 18F-FDG PET-CT; lung

Outcome Measures

Primary Outcomes (1)

• 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.

  13 months

Secondary Outcomes (3)

• 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

• 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

• Correlating brain metabolism to the volume of damage to the lung sequelae of Covid-19.

  13 months

Study Arms (1)

Patients enrolled in Neurocog-Covid study in Nancy hospital

EXPERIMENTAL

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

Interventions

18F-FDG PET-CT DEVICE

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

Patients enrolled in Neurocog-Covid study in Nancy hospital

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU NANCY Brabois, nuclear medicine department

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Antoine VERGER, MD, PhD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Patients with sequential psycho-cognitive disorders following severe COVID-19 and included in the Neurocog-Covid study

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 21, 2021
• Study Start: November 17, 2021
• Primary Completion: August 15, 2023
• Study Completion: November 27, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

FR (1)