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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDG PET | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDG PET | Other | Brain FDG PET performed 3 months after treatment initiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 analysis of initial brain FDG PET |
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Inclusion Criteria:
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)
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurélie Kas, Pr | Contact | 01 42 17 62 81 | aurelie.kas@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| AurĂ©lie Kas, Pr | HĂ´pital PitiĂ© SalpĂªtrière - Assistance Publique HĂ´pitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pitie Salpetriere | Recruiting | Paris | 75013 | France |
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.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D020274 | Autoimmune Diseases of the Nervous System |
| C567657 | Cortical Dysplasia-Focal Epilepsy Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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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 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 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 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 |
| 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) |