Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism

NCT06079294 | Recruiting

• 1 other identifier: APHP221163
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Encephalitis

Keywords

Autoimmune Encephalitis; PET; FDG; NMDAr; LGI1; CASPR2; GAD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Analysis of follow-up brain FDG PET

  PET performed 3 months after treatment initiation, compared to initial brain PET

• Secondary analysis of initial brain FDG PET

  PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)

• Secondary analysis of initial brain FDG PET

  PET performed at the acute phase, before immunomodulating treatment (or within 10 days of treatment initiation)

• Secondary analysis of initial brain FDG PET

  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

  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

Study Arms (1)

FDG PET

EXPERIMENTAL

Other: FDG PET

Interventions

FDG PET OTHER

Brain FDG PET performed 3 months after treatment initiation

FDG PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Pitie Salpetriere

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System; Cortical Dysplasia-Focal Epilepsy Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Aurélie Kas, Pr

  Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélie Kas, Pr

CONTACT

01 42 17 62 81; aurelie.kas@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: May 31, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)