Autoimmune Encephalitis Clinical Trial
— PEAOfficial title:
FDG-PET in the Diagnosis of Autoimmune Encephalitis
NCT number | NCT06019975 |
Other study ID # | PEA |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2023 |
Est. completion date | April 30, 2024 |
The goal of this retrospective observational study is to compare brain fluorodeoxyglucose-positron emission tomography (FDG-PET) of patients with autoimmune encephalitis, normal controls and patients with Alzheimer's disease (AD). The main question it aims to answer is: •is there a specific pattern of brain metabolism in patients with autoimmune encephalitis Participants data and images will be retrospectively collected from hospital records, and FDG-PET images will be analyzed by means of statistical parametric mapping (SPM). Controls will be selected from validated public databases.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | April 30, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Diagnosis of autoimmune encephalitis according to clinical criteria - Brain magnetic resonance imaging performed between clinical presentation and treatment - Cerebrospinal fluid analysis performed between clinical presentation and treatment - Brain FDG-PET performed between clinical presentation and treatment - Autoantibodies testing performed between clinical presentation and treatment Exclusion Criteria: - Refusal to give consent for the study |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Ospedale Policlinico San Martino | Genova | Liguria |
Italy | Fondazione IRCCS Istituto Neurologico "Carlo Besta" | Milano | |
Italy | Ospedale San Paolo | Milano | |
Italy | Fondazione IRCCS San Gerardo dei Tintori | Monza | Monza E Della Brianza |
Italy | Fondazione IRCCS Mondino | Pavia | Lombardia |
Italy | Azienda Sanitaria Universitaria Friuli Centrale | Udine | Friuli Venezia Giulia |
Lead Sponsor | Collaborator |
---|---|
University of Milano Bicocca |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SPM analysis of brain metabolic pattern | Pattern of brain metabolism in patients with autoimmune encephalitis compared with healthy controls and patients with Alzheimer's disease, drawn from validated published databases | up to 6 months | |
Secondary | Sensitivity of basal ganglia hypermetabolism | Sensitivity of basal ganglia hypermetabolism for the diagnosis of autoimmune encephalitis | up to 6 months | |
Secondary | Diagnostic delay | Comparison of diagnostic delay with and without FDG-PET | up to 6 months |
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