ClinicalTrials.gov record NCT06079294

Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism

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

Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism : a Prospective FDG PET Study

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationFrance
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 prospective interventional study plans to enroll 56 adults with confirmed autoimmune encephalitis. Participants will have a brain FDG PET scan in the acute phase (before immunomodulating treatment or within 10 days of starting treatment) and a follow-up PET about 3 months after treatment initiation. The study uses automated quantitative PET analyses to describe and compare initial and follow-up patterns.

What it is studying. The study is testing how often and where brain FDG PET shows abnormalities in patients with confirmed autoimmune encephalitis when performed in the acute phase, and how those PET findings change at about 3 months. It will also compare PET results with clinical features, MRI, cerebrospinal fluid and EEG, perform subgroup analyses by autoantibody status (including seronegative cases), and assess whole-body FDG PET for finding tumors in paraneoplastic cases.

What the researchers hope to learn. Conduct a prospective evaluation of the diagnostic value and patterns of brain FDG PET in confirmed autoimmune encephalitis; estimate the proportion of patients with PET abnormalities overall and by brain region; compare initial and follow-up PET; perform subgroup analyses by autoantibody subtype or seronegative status; correlate PET results with clinical variables, MRI, CSF, and EEG; perform PET voxel-wise connectivity analysis; evaluate whole-body FDG PET performance for detecting neoplasms in paraneoplastic syndromes.

What this study is about

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

Prospective cohort study evaluating FDG PET in 56 patients with confirmed autoimmune encephalitis - based on 2016 Graus criteria, and 2021 paraneoplastic neurological syndromes criteria - at the acute phase, before immunomodulating treatment, or within 10 days of treatment initiation.

Interventions being studied

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

Other
  • FDG PET

Eligibility

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

Inclusion criteria

  • Age ≥ 18 years old
  • Newly diagnosed autoimmune encephalitis based on at least 1 of the 3 following criteria :
  • " Definite limbic autoimmune encephalitis " according to 2016 Graus et al. criteria
  • " Possible autoimmune encephalitis " according to 2016 Graus et al. criteria AND typical autoantibody detected in serum or CSF
  • " Probable or certain paraneoplastic neurological syndrome " according to Graus et al. 2021 criteria (excluding peripheral neurological syndromes)
  • Less than 6 months since first neurological symptoms imputable to autoimmune encephalitis
  • Affiliated or entitled to a social security system (except AME)
  • Obtaining free, written and informed consent (patient or legal representative or the close relative)

Exclusion criteria

  • History of brain tumor, head trauma, infarction or cerebral hematoma likely to result in altered cerebral carbohydrate metabolism on PET
  • Patients who hae been on immunotherapy (corticosteroid bolus, IVIg, plasma exchange, endoxan, rituximab or other immunotherapy) fr more than 10 days
  • Pregnant or breast-feeding woman
  • Ventilated intubated patient
  • Absolute contraindication to MRI (Pacemaker, cochlear implant, etc.)
  • Presence of cognitive disorders incompatible with goog cooperation with the PET scan
  • Algic or agitated patient unable to remain immobile in supine position for 30 minutes
  • Deprived of liberty or under a protective measure (guardianship or curatorship)
  • Patient taking part in other interventional research involving radiopharmaceutical injections

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Autoimmune encephalitis is a diagnostic challenge, and requires early diagnosis for improved neurological outcomes. FDG PET has shown very high sensitivity, suggesting better performances than MRI, but almost exclusively in small sized retrospective studies. Brain FDG PET is therefore not included in current diagnostic criteria, conversely to brain MRI. This study will include 56 patients with confirmed - seropositive or seronegative - autoimmune encephalitis, based on 2016 Graus criteria for autoimmune encephalitis and 2021 criteria for paraneoplastic neurological syndromes. The main objective is to conduct a prospective evaluation of the diagnostic value of FDG PET performed in the acute phase before treatment initiation, or within 10 days of treatment initiation. A follow-up PET performed 3 months after treatment initiation will also be performed and analysed for all patients as part of secondary objective analyses.

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.

Participants will undergo an initial brain FDG PET scan in the acute phase (before immunomodulating treatment or within 10 days of starting treatment) and a follow-up brain FDG PET about 3 months after treatment start. Some participants may also have a whole‑body FDG PET at the initial assessment. The study team will collect clinical data and existing test results (for example MRI, cerebrospinal fluid findings, and EEG) to compare with the PET results. For PET scans you must be able to lie still on your back for about 30 minutes and be able to cooperate with imaging.

How the study is structured. Interventional, single-group study with no masking. All participants receive brain FDG PET at the acute phase (before immunomodulating treatment or within 10 days of starting) and a follow-up brain FDG PET about 3 months after treatment initiation. Automated region-based and voxel-wise quantitative analyses will be applied to the scans.

Questions you could ask

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

  • The listed sites are in France. 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
May 31, 2024
Primary completion
Apr 30, 2026 (estimated)
Study completion
May 31, 2026 (estimated)
Target enrollment
56 participants (estimated)
Last updated on registry
Aug 22, 2025
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
Assistance Publique - Hôpitaux de Paris

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 (1)

Terms used on this page · explanations by MedicalUpdates.ai

Prospective cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
PET
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.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
legal representative
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
corticosteroid
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
contraindication
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
MRI
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.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
secondary objective
An additional result the study measures alongside the primary outcome, for example quality of life or a laboratory value.

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.

← Back to clinical trials