FDG-PET in the Diagnosis of Autoimmune Encephalitis (PEA)

March 23, 2026 updated by: University of Milano Bicocca

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Friuli Venezia Giulia
      • Udine, Friuli Venezia Giulia, Italy
        • Not yet recruiting
        • Azienda Sanitaria Universitaria Friuli Centrale
        • Contact:
        • Principal Investigator:
          • Alberto Vogrig, MD, PhD
    • Liguria
      • Genoa, Liguria, Italy
        • Not yet recruiting
        • IRCCS Ospedale Policlinico San Martino
        • Contact:
        • Principal Investigator:
          • Flavio Villani, MD
    • Lombardy
      • Pavia, Lombardy, Italy
        • Recruiting
        • Fondazione IRCCS Mondino
        • Contact:
        • Principal Investigator:
          • Matteo Gastaldi, MD
    • Milano
      • Milan, Milano, Italy, 20133
        • Not yet recruiting
        • Fondazione IRCCS Istituto Neurologico "Carlo Besta"
        • Contact:
          • Francesco Deleo, MD, PhD
        • Principal Investigator:
          • Francesco Deleo, MD, PhD
        • Sub-Investigator:
          • Andrea Stabile, MD
      • Milan, Milano, Italy, 20142
        • Not yet recruiting
        • Ospedale San Paolo
        • Contact:
          • Francesco Del Sole, MD, PhD
        • Principal Investigator:
          • Francesco Del Sole, MD, PhD
    • Monza e Della Brianza
      • Monza, Monza e Della Brianza, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
        • Contact:
        • Sub-Investigator:
          • Federico Emanuele Pozzi, MD
        • Sub-Investigator:
          • Cinzia Crivellaro, MD
        • Contact:
        • Principal Investigator:
          • Simone Beretta, MD, PhD
        • Sub-Investigator:
          • Angela Giglio, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with autoimmune encephalitis admitted to the recruiting centers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Brain FDG-PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SPM analysis of brain metabolic pattern
Time Frame: 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
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of basal ganglia hypermetabolism
Time Frame: up to 6 months
Sensitivity of basal ganglia hypermetabolism for the diagnosis of autoimmune encephalitis
up to 6 months
Diagnostic delay
Time Frame: up to 6 months
Comparison of diagnostic delay with and without FDG-PET
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Investigators

  • Principal Investigator: Simone Beretta, MD, PhD, University of Milano Bicocca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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