FDG-PET in the Diagnosis of Autoimmune Encephalitis

NCT06019975 | Recruiting

• 1 other identifier: PEA
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 6

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.

Conditions

Autoimmune Encephalitis

Keywords

Autoimmune Encephalitis; FDG-PET; SPM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sensitivity of basal ganglia hypermetabolism

  up to 6 months

• Diagnostic delay

  up to 6 months

Study Arms (1)

Autoimmune Encephalitis patients

Patients with autoimmune encephalitis admitted to the centers, who underwent a brain FDG-PET during the course of their disease trajectory.

Diagnostic Test: FDG-PET

Interventions

FDG-PET DIAGNOSTIC_TEST

Brain FDG-PET

Autoimmune Encephalitis patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with autoimmune encephalitis admitted to the recruiting centers

You may qualify if:

• 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

You may not qualify if:

• Refusal to give consent for the study

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (6)

Azienda Sanitaria Universitaria Friuli Centrale

Udine, Friuli Venezia Giulia, Italy

NOT YET RECRUITING

IRCCS Ospedale Policlinico San Martino

Genoa, Liguria, Italy

NOT YET RECRUITING

Fondazione IRCCS Mondino

Pavia, Lombardy, Italy

RECRUITING

Fondazione IRCCS Istituto Neurologico "Carlo Besta"

Milan, Milano, 20133, Italy

NOT YET RECRUITING

Ospedale San Paolo

Milan, Milano, 20142, Italy

NOT YET RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza e Della Brianza, 20900, Italy

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Simone Beretta, MD, PhD

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Beretta, MD, PhD

CONTACT

+390392333568; simone.beretta@unimib.it

Federico Emanuele Pozzi, MD

CONTACT

federicoemanuele.pozzi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 31, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)