Hospital Pitie Salpetriere
Paris, 75013, France
Location status: Recruiting
NCT Number: NCT06079294
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Paris, 75013, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Brain FDG PET performed 3 months after treatment initiation
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).
Time frame: PET performed 3 months after treatment initiation, compared to initial brain PET
Automated region-based and voxel wise quantitative PET analysis comparatively to initial brain PET
Time frame: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
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)
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)
PET voxel-wise connectivity analysis
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
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)
Evaluation of whole body FDG PET diagnostic performance for identifying neoplasms in paraneoplastic syndromes
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism : a Prospective FDG PET Study
Acronym: ENCEPHATAIP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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