Image

Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism

Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

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.

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

Study details
    Autoimmune Encephalitis

NCT06079294

Assistance Publique - Hôpitaux de Paris

17 June 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.