## Protocol Section
### Identification Module
**NCT ID:** NCT06432803

**Acronym:** MIDAS

**Brief Title:** Metabolic Imaging for Diagnosis and Prognostication of Autoimmune encephalitiS

**Official Title:** Metabolic Imaging for Diagnosis and Prognostication of Autoimmune encephalitiS

#### Organization Study ID Info
**ID:** 69HCL24_0511
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospices Civils de Lyon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 (e.g., 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 it's best to parametrize the brain's 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 cortex/striatal metabolic ratio is a robust biomarker for the early diagnosis of AE.

### Conditions Module

**Conditions:**

- Paraneoplastic Neurological Syndrome

- Autoimmune Encephalitis

**Keywords:**

- Paraneoplastic neurological disorders

- autoimmune encephalitis

- auto-antibodies

- PET-SCAN

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 28

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Analysis of PET-scan

**Intervention Names:**

- Other: PET-Scan analysis

**Label:** Auto-immune encephalitis patients

#### Arm Group 2

**Description:** Analysis of PET-scan

**Intervention Names:**

- Other: PET-Scan analysis

**Label:** Paraneoplastic Neurological Syndromes patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Auto-immune encephalitis patients

- Paraneoplastic Neurological Syndromes patients

**Description:** Investigate and determine the clinical value of different cortex/striatal metabolic ratio patterns in each antibody-specific subtype of autoimmune encephalitis

**Name:** PET-Scan analysis

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Decrease in the metabolic ratio cortex/striatum in included patients, compared to a control reference cohort.

**Measure:** Ratio metabolic cortex-striatum

**Time Frame:** Up to 10 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* patient with positivity of auto-antibody in CSF
* patient \>18 years old
* patient with auto-immune encephalitis or paraneoplastic neurological syndrome

Exclusion Criteria:

- patient without data

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients will be included from the from the database of the French Reference Centre for Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis (Lyon, France)

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Pierre-Bénite

**Country:** France

**Facility:** CHU Lyon

**Zip:** 69495

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000090862

- Term: Neuroinflammatory Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

- ID: D000013967

- Term: Thyroiditis, Autoimmune

- ID: D000013966

- Term: Thyroiditis

- ID: D000013959

- Term: Thyroid Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M7825

- Name: Encephalitis

- Relevance: HIGH

- As Found: Encephalitis

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22094

- Name: Autoimmune Diseases of the Nervous System

- Relevance: HIGH

- As Found: Autoimmune Encephalitis

- ID: M26156

- Name: Hashimoto Disease

- Relevance: HIGH

- As Found: Autoimmune Encephalitis

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2803

- Name: Neuroinflammatory Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16725

- Name: Thyroiditis

- Relevance: LOW

- As Found: Unknown

- ID: M16726

- Name: Thyroiditis, Autoimmune

- Relevance: LOW

- As Found: Unknown

- ID: M16718

- Name: Thyroid Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T554

- Name: Autoimmune Encephalitis

- Relevance: HIGH

- As Found: Autoimmune Encephalitis

- ID: T2673

- Name: Hashimoto Encephalopathy

- Relevance: HIGH

- As Found: Autoimmune Encephalitis

- ID: T3542

- Name: Lymphomatous Thyroiditis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004660

- Term: Encephalitis

- ID: D000020274

- Term: Autoimmune Diseases of the Nervous System

- ID: D000050031

- Term: Hashimoto Disease

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M4625

- Name: Autoantibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
