Autoimmune Encephalitis Clinical Trial
— ENCEPHATAIPOfficial title:
Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism : a Prospective FDG PET Study
NCT number | NCT06079294 |
Other study ID # | APHP221163 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 31, 2024 |
Est. completion date | May 31, 2026 |
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.
Status | Recruiting |
Enrollment | 56 |
Est. completion date | May 31, 2026 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years old - Newly diagnosed autoimmune encephalitis based on at least 1 of the 3 following criteria : 1. " Definite limbic autoimmune encephalitis " according to 2016 Graus et al. criteria 2. " Possible autoimmune encephalitis " according to 2016 Graus et al. criteria AND typical autoantibody detected in serum or CSF 3. " 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 |
Country | Name | City | State |
---|---|---|---|
France | Hospital Pitie Salpetriere | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation) | |
Secondary | Analysis of follow-up brain FDG PET | Automated region-based and voxel wise quantitative PET analysis comparatively to initial brain PET | PET performed 3 months after treatment initiation, compared to initial brain PET | |
Secondary | Secondary analysis of initial brain FDG PET | Subgroup PET analysis according to autoantibody subtype or seronegative status | PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation) | |
Secondary | 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).) | PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation) | |
Secondary | Secondary analysis of initial brain FDG PET | PET voxel-wise connectivity analysis | PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation) | |
Secondary | Secondary analysis of initial and follow-up brain FDG PET | Correlation of PET treatment response to clinical symptom treatment response | 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 | |
Secondary | Analysis of initial whole body FDG PET | Evaluation of whole body FDG PET diagnostic performance for identifying neoplasms in paraneoplastic syndromes | PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation) |
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