Autoimmune EncephalitisENCEPHATAIPNCT06079294
Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism
A study testing FDG PET in people with Autoimmune Encephalitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Encephalitis
- What is being tested?
- FDG PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2024to 31 May 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospital Pitie Salpetriere
Paris, 75013
Aurélie Kas, Pr, 01 42 17 62 81, aurelie.kas@aphp.fr
About this study
Official title: Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism : a Prospective FDG PET Study
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.
Read the detailed description
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.
- Conditions
- Autoimmune Encephalitis
- Being tested
- FDG PET
- Keywords
- Autoimmune Encephalitis, PET, FDG, NMDAr, LGI1, CASPR2, GAD
- Medical subject headings
- Autoimmune Diseases of the Nervous System, Cortical Dysplasia-Focal Epilepsy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PETOther
Brain FDG PET performed 3 months after treatment initiation
| Study group | Role | What they receive |
|---|---|---|
| FDG PET | Experimental | Not described Receives: Other: FDG PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main analysis of initial brain FDG PET
Automated region-based and voxel wise quantitative PET analysis, estimation of the proportion of patients with PET anomalies (overall and by region of interest).
Measured: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Secondary outcomes (6)
Analysis of follow-up brain FDG PET
Automated region-based and voxel wise quantitative PET analysis comparatively to initial brain PET
Measured: PET performed 3 months after treatment initiation, compared to initial brain PET
Secondary analysis of initial brain FDG PET
Subgroup PET analysis according to autoantibody subtype or seronegative status
Measured: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Secondary analysis of initial brain FDG PET
Correlation of main analysis results to important clinical variables (clinical symptomatology (typology and duration of symptoms), MRI, cerebrospinal fluid (CSF), electroencephalogram (EEG).)
Measured: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Secondary analysis of initial brain FDG PET
PET voxel-wise connectivity analysis
Measured: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Secondary analysis of initial and follow-up brain FDG PET
Correlation of PET treatment response to clinical symptom treatment response
Measured: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation), and follow-up PET 3 months after treatment initiation
Analysis of initial whole body FDG PET
Evaluation of whole body FDG PET diagnostic performance for identifying neoplasms in paraneoplastic syndromes
Measured: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start31 May 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion31 May 2026 (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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie Kas, Pr, Principal investigator, Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079294
- Sponsor's protocol ID
- APHP221163
- Acronym
- ENCEPHATAIP
- Status last verified
- Aug 2025
- First submitted
- 6 Oct 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism : a Prospective FDG PET Study
- ClinicalTrials.gov ID
- NCT06079294
- Acronym / sponsor ID
- ENCEPHATAIP / APHP221163
- Conditions
- Autoimmune Encephalitis
- Keywords
- Autoimmune Encephalitis, PET, FDG, NMDAr, LGI1, CASPR2, GAD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 12 Oct 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG PET | Experimental | Other: FDG PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years old
- Newly diagnosed autoimmune encephalitis based on at least 1 of the 3 following criteria :
- 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)
Key exclusion criteria (9 listed)
- 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.)
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 performed 3 months after treatment initiation | Other | FDG PET |
Primary outcome
Main analysis of initial brain FDG PET
Time frame: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Automated region-based and voxel wise quantitative PET analysis, estimation of the proportion of patients with PET anomalies (overall and by region of interest).
6 secondary outcomes
Analysis of follow-up brain FDG PET
Time frame: PET performed 3 months after treatment initiation, compared to initial brain PET
Secondary analysis of initial brain FDG PET
Time frame: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Secondary analysis of initial brain FDG PET
Time frame: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Secondary analysis of initial brain FDG PET
Time frame: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Secondary analysis of initial and follow-up brain FDG PET
Time frame: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation), and follow-up PET 3 months after treatment initiation
Analysis of initial whole body FDG PET
Time frame: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
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 22 Aug 2025.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Aurélie Kas, Pr principal investigator
Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG PET in people with Autoimmune Encephalitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 9 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 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Aurélie Kas, Pr (01 42 17 62 81, aurelie.kas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main analysis of initial brain FDG PET (time frame: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)). 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 22 Aug 2025.