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Neuroinflammatory PET Imaging in Autoimmune Encephalomyelitis

Neuroinflammatory Imaging Using TSPO PET Tracer in Paients With Autoimmune Encephalomyelitis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05293405
Enrollment
100
Registered
2022-03-24
Start date
2021-12-14
Completion date
2024-12-31
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Encephalomyelitis

Brief summary

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.

Interventions

DIAGNOSTIC_TEST18F-DPA-714 PET

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

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Experimental group: 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.

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: Inclusion criteria: 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

Design outcomes

Primary

MeasureTime frameDescription
TSPO expression levelBaselinequantitatively assessing the level of neuroinflammation in all brain regions or spinal cord

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026