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Paraneoplastic Neurological SyndromeMIDASNCT06432803

Metabolic Imaging for Diagnosis and Prognostication of Autoimmune encephalitiS

An observational study of Paraneoplastic Neurological Syndrome and Autoimmune Encephalitis, run by Hospices Civils de Lyon at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PET-Scan analysis
How many people
28 participants
Where
1 siteFrance
Study dates
1 Mar 2024to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • 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)

Who may be able to join

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

Who cannot join

  • patient without data

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU Lyon

    Pierre-Bénite, 69495

Other trials in France

About this study

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.

Being tested
PET-Scan analysis
Keywords
Paraneoplastic neurological disorders, autoimmune encephalitis, auto-antibodies, PET-SCAN
Medical subject headings
Autoimmune Diseases of the Nervous System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET-Scan analysisOther

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

Study groups in NCT06432803
Study groupRoleWhat they receive
Auto-immune encephalitis patientsAnalysis of PET-scan
Receives: Other: PET-Scan analysis
Paraneoplastic Neurological Syndromes patientsAnalysis of PET-scan
Receives: Other: PET-Scan analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ratio metabolic cortex-striatum

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

    Measured: Up to 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06432803
Sponsor's protocol ID
69HCL24_0511
Acronym
MIDAS
Status last verified
May 2024
First submitted
14 May 2024
Last updated
29 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Paraneoplastic Neurological Syndrome and Autoimmune Encephalitis, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratio metabolic cortex-striatum (time frame: Up to 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.

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