Neuroinflammatory PET Imaging in Autoimmune Encephalomyelitis

Neuroinflammatory Imaging Using TSPO PET Tracer in Paients With Autoimmune Encephalomyelitis

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.

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Encephalomyelitis
• Intervention / Treatment: Diagnostic test: 18F-DPA-714 PET

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200025
    • Recruiting
    • Ruijin Hospital
    • Contact: Min Zhang, Dr.; Phone Number: 0086-21-64370045; Email: zm11518@rjh.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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"

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Healthy Volunteers Group	Diagnostic test: 18F-DPA-714 PET; TSPO expression are quantitatively analyzed in all brain regions or spinal cord using 18F-DPA-714 PET
Experimental: Patients Group	Diagnostic test: 18F-DPA-714 PET; TSPO expression are quantitatively analyzed in all brain regions or spinal cord using 18F-DPA-714 PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TSPO expression level	quantitatively assessing the level of neuroinflammation in all brain regions or spinal cord	Baseline
TSPO expression level	quantitatively assessing the level of neuroinflammation in all brain regions or spinal cord	3 months after baseline
TSPO expression level	quantitatively assessing the level of neuroinflammation in all brain regions or spinal cord	12 months after baseline

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2021
• Primary Completion (Anticipated): December 13, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Central Nervous System Infections; Leukoencephalopathies; Nervous System Autoimmune Disease, Experimental; Encephalomyelitis; Encephalomyelitis, Autoimmune, Experimental
• Other Study ID Numbers: (2021)CER(375)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No