Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-01-07 @ 6:17 AM
Study NCT ID:
NCT06079294
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2023-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism : a Prospective FDG PET Study
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENCEPHATAIP
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: