ClinicalTrials.gov record NCT06019975

FDG-PET in the Diagnosis of Autoimmune Encephalitis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

FDG-PET in the Diagnosis of Autoimmune Encephalitis

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationItaly
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This retrospective observational study collects existing brain FDG-PET scans and clinical data from people diagnosed with autoimmune encephalitis. Images will be analyzed using statistical parametric mapping (SPM) and compared with healthy controls and people with Alzheimer's disease to look for specific metabolic patterns. The study also examines basal ganglia hypermetabolism and compares diagnostic delay with and without FDG-PET.

What it is studying. Whether people with autoimmune encephalitis show a specific pattern of brain metabolism on FDG-PET compared with healthy controls and Alzheimer's disease, plus the sensitivity of basal ganglia hypermetabolism and whether FDG-PET is associated with differences in diagnostic delay.

What the researchers hope to learn. To describe metabolic brain patterns in autoimmune encephalitis, assess whether basal ganglia hypermetabolism is a sensitive diagnostic feature, and compare diagnostic delay with and without FDG-PET.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • FDG-PET

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Researchers will collect and review your existing hospital records and brain FDG‑PET images from the time of your illness. The FDG‑PET images will be analyzed using statistical parametric mapping (SPM) and compared with control databases. You would be asked to give consent for use of your past tests and records; the study is retrospective and uses information already in medical records.

How the study is structured. A retrospective observational cohort study: researchers will gather past clinical records and brain FDG-PET images from people with autoimmune encephalitis, analyze the images with SPM, and compare results to validated public databases of healthy controls and Alzheimer's disease.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune encephalitis

Clinical trials40 trials listed for autoimmune encephalitisEvery trial the registry lists for autoimmune encephalitis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune encephalitis researchLatest monthly update: September 2026. Includes: Efgartigimod reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 1, 2023
Primary completion
Mar 31, 2027 (estimated)
Study completion
Apr 30, 2027 (estimated)
Target enrollment
90 participants (estimated)
Last updated on registry
Mar 24, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Milano Bicocca

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (6)

  • Azienda Sanitaria Universitaria Friuli CentraleNot Yet Recruiting

    Udine, Friuli Venezia Giulia · Italy

  • IRCCS Ospedale Policlinico San MartinoNot Yet Recruiting

    Genoa, Liguria · Italy

  • Fondazione IRCCS MondinoRecruiting

    Pavia, Lombardy · Italy

  • Fondazione IRCCS Istituto Neurologico "Carlo Besta"Not Yet Recruiting

    Milan, Milano, 20133 · Italy

    • Francesco Deleo, MD, PhD
    • Francesco Deleo, MD, PhD
    • Andrea Stabile, MD
  • Ospedale San PaoloNot Yet Recruiting

    Milan, Milano, 20142 · Italy

    • Francesco Del Sole, MD, PhD
    • Francesco Del Sole, MD, PhD
  • Fondazione IRCCS San Gerardo dei TintoriRecruiting

    Monza, Monza e Della Brianza, 20900 · Italy

Terms used on this page · explanations by MedicalUpdates.ai

positron emission tomography
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
magnetic resonance imaging
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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