Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432803
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-14
Brief Title:
Metabolic Imaging for Diagnosis and Prognostication of Autoimmune encephalitiS
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Metabolic Imaging for Diagnosis and Prognostication of Autoimmune encephalitiS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
MIDAS
Brief Summary:
Autoimmune encephalitis AE is a rare neurological disorder mediated by autoimmune antibody response against neuronal cell surface and intraneuronal proteins associated with specific brain areas resulting in severe inflammation and damage in the associated brain regions all most frequently manifesting diverse cognition and memory impairment symptoms at follow-up However these symptoms may co-exist or mimic other CNS autoimmune and neurodegenerative disorders The most common guideline for diagnosing autoimmune encephalitis relies on cerebrospinal fluid CSF antibody testing which might take several weeks to obtain making it not optimal for the early diagnosis of AE As for magnetic resonance imaging MRI which is the most common imaging tool utilized for aiding in the diagnosis of AE can possess several limitations as some patients like anti-NMDAr AE patients can present memory and behavioral deficits even in the presence of normal brain MRI Positron emission tomography PET with 2-deoxy-2-fluorine-18 fluoro-D-glucose 18F-FDG have been addressed by several studies as an important examination for the early diagnosis of AE One study demonstrated that the fraction of having an abnormal MRI in AE patients is lower than having an abnormal PET by which certain PET patterns were associated with autoantibody types of AE Moreover one report demonstrated that even with autoantibody negative test and normal brain MRI FDG-PET examination showed abnormal hypometabolism and hypermetabolism patterns More specifically these distinct patterns include medial temporal and striatal hypermetabolism with cortical diffuse hypometabolism Leiris et al revealed that the methadology used for the analysis of these PET images is highly variable especially intensity normalization methods where most possess some limitations eg proportional scaling as they can impede the accurate differential diagnosis of autoimmune encephalitis AE by potentially indicating false hypermetabolism in otherwise preserved brain regions Absolute quantification is not possible since the disease presents both diffuse hypometabolism and hypermetabolism on PET images So they suggested that its best to parametrize the brains activity by dividing it by that of the striatum Their voxel-based analysis comparing individuals with AE to both healthy subjects and those with mild cognitive impairment MCI demonstrated that a decrease in the cortexstriatal metabolic ratio is a robust biomarker for the early diagnosis of AE
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None