Back to resultsImpact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism (ENCEPHATAIP)
Primary Purpose
Autoimmune Encephalitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FDG PET
Sponsored by
About this trial
This is an interventional basic science trial for Autoimmune Encephalitis focused on measuring Autoimmune Encephalitis, PET, FDG, NMDAr, LGI1, CASPR2, GAD
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old Newly diagnosed autoimmune encephalitis based on at least 1 of the 3 following criteria : " 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) 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
Sites / Locations
- Hospital Pitie Salpetriere
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FDG PET
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Analysis of follow-up brain FDG PET
Automated region-based and voxel wise quantitative PET analysis comparatively to initial brain PET
Secondary analysis of initial brain FDG PET
Subgroup PET analysis according to autoantibody subtype or seronegative status
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).)
Secondary analysis of initial brain FDG PET
PET voxel-wise connectivity analysis
Secondary analysis of initial and follow-up brain FDG PET
Correlation of PET treatment response to clinical symptom treatment response
Analysis of initial whole body FDG PET
Evaluation of whole body FDG PET diagnostic performance for identifying neoplasms in paraneoplastic syndromes
Full Information
NCT ID
NCT06079294
First Posted
October 6, 2023
Last Updated
October 16, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT06079294
Brief Title
Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism
Acronym
ENCEPHATAIP
Official Title
Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism : a Prospective FDG PET Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 4, 2024 (Anticipated)
Primary Completion Date
November 4, 2025 (Anticipated)
Study Completion Date
January 4, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Encephalitis
Keywords
Autoimmune Encephalitis, PET, FDG, NMDAr, LGI1, CASPR2, GAD
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FDG PET
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
FDG PET
Intervention Description
Brain FDG PET performed 3 months after treatment initiation
Primary Outcome Measure Information:
Title
Main analysis of initial brain FDG PET
Description
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 Outcome Measure Information:
Title
Analysis of follow-up brain FDG PET
Description
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
Title
Secondary analysis of initial brain FDG PET
Description
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)
Title
Secondary analysis of initial brain FDG PET
Description
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)
Title
Secondary analysis of initial brain FDG PET
Description
PET voxel-wise connectivity analysis
Time Frame
PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Title
Secondary analysis of initial and follow-up brain FDG PET
Description
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
Title
Analysis of initial whole body FDG PET
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old
Newly diagnosed autoimmune encephalitis based on at least 1 of the 3 following criteria :
" 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)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie Kas, Pr
Phone
01 42 17 62 81
Email
aurelie.kas@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie Kas, Pr
Organizational Affiliation
Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie Kas, Pr
Phone
01 42 17 62 81
Email
aurelie.kas@aphp.fr
12. IPD Sharing Statement
Learn more about this trial
Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism
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