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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date December 2023
Source University of Milano Bicocca
Contact Simone Beretta, MD, PhD
Phone +390392333568
Email simone.beretta@unimib.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
FDG-PET
Brain FDG-PET

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

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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