Neuroinflammatory PET Imaging in Autoimmune Encephalomyelitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-14

Study Completion Date

2024-12-31

Brief Summary

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Autoimmune encephalomyelitis is a heterogeneous group of central nervous system (CNS) autoimmune diseases characterized by the production of anti-neuron-associated autoantibodies which target neuronal surface proteins, synaptic receptors and intracellular antigens. MRI, as a current first-line imaging tool of CNS inflammation, is difficult to diagnose them because the majority of patients have normal MRI images, and only a few may show local signal or structural abnormalities (including inflammation, edema, or atrophy). The 18 kDa translocator protein (TSPO) expression in the CNS is upregulated in response to microglia activation. DPA-714 is high affinity for binding to TSPO, making 18F-labeled DPA-714 (18F-DPA-714) PET a very promising diagnostic imaging tool for neuroinflammation in patients with autoimmune encephalomyelitis.This study aims to explore the value of 18F-DPA-714 PET in the early diagnosis, therapeutic assessment and prognosis in patients with autoimmune encephalomyelitis.

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Detailed Description

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Conditions

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Autoimmune Encephalomyelitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients Group

Group Type EXPERIMENTAL

18F-DPA-714 PET

Intervention Type DIAGNOSTIC_TEST

TSPO expression are quantitatively analyzed in all brain regions or spinal cord using 18F-DPA-714 PET

Healthy Volunteers Group

Group Type SHAM_COMPARATOR

18F-DPA-714 PET

Intervention Type DIAGNOSTIC_TEST

TSPO expression are quantitatively analyzed in all brain regions or spinal cord using 18F-DPA-714 PET

Interventions

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18F-DPA-714 PET

TSPO expression are quantitatively analyzed in all brain regions or spinal cord using 18F-DPA-714 PET

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patients with onset for less than 2 years
2. Serum autoantibody positive
3. cognitive impairment or movement disorder diagnosed by two or more certified specialists.

1. able to understand the purpose of clinical research and test plan
2. In the brain and spine cord MR assessment, it is judged as "normal"

Exclusion Criteria

1. Patients who do not meet the clinical、laboratory and imaging criteria of immune-related cognitive and movement disorders
2. Medical history of surgery, trauma, stroke, tumor in brain or spine cord
3. Alcoholism or drug dependence (addiction)
4. Patients with pregnancy

Healthy Volunteers group:

1. Any major mental illness; history of schizophrenia or schizoaffective disorder
2. Any important neurological disease, such as cerebrovascular disease, inflammation or infectious disease, demyelinating disease, neurodegenerative disease, trauma in brain or spine cord
3. History of alcohol or drug abuse/dependence
4. Medical history of cardiac and lung disease, tumors, blood disease, poorly controlled chronic diseases
5. Patients with pregnancy

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes