Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old

" 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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • FDG PET

    Other intervention

    Brain FDG PET performed 3 months after treatment initiation

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: FDG PETExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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
2

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)
3

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)
4

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)

Other outcomes

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