Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism (ENCEPHATAIP)

November 20, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism : a Prospective FDG PET Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75013
        • Hospital Pitie Salpetriere
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FDG PET
Other: FDG PET
Brain FDG PET performed 3 months after treatment initiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main analysis of initial brain FDG PET
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).
PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of follow-up brain FDG PET
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
PET performed 3 months after treatment initiation, compared to initial brain PET
Secondary analysis of initial brain FDG 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
PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Secondary analysis of initial brain FDG PET
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).)
PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
Secondary analysis of initial brain FDG PET
Time Frame: PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)
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
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
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
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
PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Aurélie Kas, Pr, Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 4, 2024

Primary Completion (Estimated)

November 4, 2025

Study Completion (Estimated)

January 4, 2026

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP221163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autoimmune Encephalitis

Clinical Trials on FDG PET

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe