An interventional study of FDG PET in Autoimmune Encephalitis, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Basic science
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.
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.
115 studies on the registry are indexed under Autoimmune Diseases of the Nervous System; 55 are open to participants now.
This study's planned enrollment of 56 is above the median of 38 across 57 interventional studies indexed under Autoimmune Diseases of the Nervous System.
Browse Autoimmune Diseases of the Nervous System studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Newly diagnosed autoimmune encephalitis based on at least 1 of the 3 following criteria :
Exclusion criteria
Other: FDG PET
Brain FDG PET performed 3 months after treatment initiation
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).
Time frame: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Analysis of follow-up brain FDG PET
Automated region-based and voxel wise quantitative PET analysis comparatively to initial brain PET
Time frame: 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
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
Correlation of main analysis results to important clinical variables (clinical symptomatology (typology and duration of symptoms), MRI, cerebrospinal fluid (CSF), electroencephalogram (EEG).)
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
PET voxel-wise connectivity analysis
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
Correlation of PET treatment response to clinical symptom treatment response
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
Evaluation of whole body FDG PET diagnostic performance for identifying neoplasms in paraneoplastic syndromes
Time frame: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
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