FDG-PET in the Diagnosis of Autoimmune Encephalitis

Recruiting

• Conditions: Autoimmune Encephalitis

• Registration Number: NCT06019975
• Lead Sponsor: University of Milano Bicocca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-02
• Primary Completion: 2024-03-31
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SPM analysis of brain metabolic pattern	up to 6 months	Pattern of brain metabolism in patients with autoimmune encephalitis compared with healthy controls and patients with Alzheimer's disease, drawn from validated published databases

Secondary Outcome Measures

Name	Time	Method
Sensitivity of basal ganglia hypermetabolism	up to 6 months	Sensitivity of basal ganglia hypermetabolism for the diagnosis of autoimmune encephalitis
Diagnostic delay	up to 6 months	Comparison of diagnostic delay with and without FDG-PET

Trial Locations

Locations (6)

Azienda Sanitaria Universitaria Friuli Centrale; 🇮🇹 Udine, Friuli Venezia Giulia, Italy

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genova, Liguria, Italy

Fondazione IRCCS Mondino; 🇮🇹 Pavia, Lombardia, Italy

Fondazione IRCCS San Gerardo dei Tintori; 🇮🇹 Monza, Monza E Della Brianza, Italy

Fondazione IRCCS Istituto Neurologico "Carlo Besta"; 🇮🇹 Milano, Italy

Ospedale San Paolo; 🇮🇹 Milano, Italy