Autoimmune EncephalitisPEANCT06019975
FDG-PET in the Diagnosis of Autoimmune Encephalitis
An observational study of Autoimmune Encephalitis, run by University of Milano Bicocca at 6 sites in Italy.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autoimmune Encephalitis
- What is being tested?
- FDG-PET
- How many people
- 90 participants
- Where
- 6 sitesItaly
- Study dates
- 1 Mar 2023to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with autoimmune encephalitis admitted to the recruiting centers
Who may be able to join
- 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
Who cannot join
- Refusal to give consent for the study
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Federico Emanuele Pozzi, MD contact
6 sites in 1 country
Italy6 sites, 6 recruiting
- Not yet recruiting
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria
Flavio Villani, MD, flavio.villani@hsanmartino.it
Flavio Villani, MD
- Not yet recruiting
Fondazione IRCCS Istituto Neurologico "Carlo Besta"
Milan, Milano, 20133
Francesco Deleo, MD, PhD
Francesco Deleo, MD, PhD
- Not yet recruiting
Ospedale San Paolo
Milan, Milano, 20142
Francesco Del Sole, MD, PhD
Francesco Del Sole, MD, PhD
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza e Della Brianza, 20900
Simone Beretta, MD, PhD, +390392333568, simone.beretta@unimib.it
Federico Emanuele Pozzi, MD, federicoemanuele.pozzi@gmail.com
- Recruiting
Fondazione IRCCS Mondino
Pavia, Lombardy
Matteo Gastaldi, MD, matteo.gastaldi@mondino.it
Matteo Gastaldi, MD
- Not yet recruiting
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Friuli Venezia Giulia
Alberto Vogrig, MD, PhD, alberto.vogrig@gmail.com
Alberto Vogrig, MD, PhD
About this study
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
- Being tested
- FDG-PET
- Keywords
- Autoimmune Encephalitis, FDG-PET, SPM
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PETDiagnostic test
Brain FDG-PET
| Study group | Role | What they receive |
|---|---|---|
| Autoimmune Encephalitis patients | Patients with autoimmune encephalitis admitted to the centers, who underwent a brain FDG-PET during the course of their disease trajectory. Receives: Diagnostic Test: FDG-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 months
Secondary outcomes (2)
Sensitivity of basal ganglia hypermetabolism
Sensitivity of basal ganglia hypermetabolism for the diagnosis of autoimmune encephalitis
Measured: up to 6 months
Diagnostic delay
Comparison of diagnostic delay with and without FDG-PET
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Mar 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Beretta, MD, PhD, Principal investigator, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019975
- Sponsor's protocol ID
- PEA
- Acronym
- PEA
- Status last verified
- Mar 2026
- First submitted
- 4 Aug 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDG-PET in the Diagnosis of Autoimmune Encephalitis
- ClinicalTrials.gov ID
- NCT06019975
- Acronym / sponsor ID
- PEA / PEA
- Conditions
- Autoimmune Encephalitis
- Keywords
- Autoimmune Encephalitis, FDG-PET, SPM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autoimmune Encephalitis patients | – | Diagnostic Test: FDG-PETPatients with autoimmune encephalitis admitted to the centers, who underwent a brain FDG-PET during the course of their disease trajectory. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with autoimmune encephalitis admitted to the recruiting centers
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to give consent for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG-PETBrain FDG-PET | Diagnostic test | Autoimmune Encephalitis patients |
Primary outcome
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
2 secondary outcomes
Sensitivity of basal ganglia hypermetabolism
Time frame: up to 6 months
Diagnostic delay
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Federico Emanuele Pozzi, MD contact
Simone Beretta, MD, PhD principal investigator
University of Milano Bicocca
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Encephalitis, run by University of Milano Bicocca at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone Beretta, MD, PhD (+390392333568, simone.beretta@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPM analysis of brain metabolic pattern (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.