18F-DPA-714 PET/MR in Dysfunctional Brain Diseases

NCT06851143 | Not Yet Recruiting

• 1 other identifier: KY20252023
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a diagnostic pilot study that recruited 25 normal volunteers and 40 patients with dysfunctional brain diseases and performed 18F-DPA-714 PET/MR imaging to evaluate the correlation between the multimodal imaging features of dysfunctional brain diseases, to explore the potential pathological mechanisms of neuroimmune activation, and to further analyse the value of PET/MR-based multimodal imaging in the diagnosis and differential diagnosis of dysfunctional brain diseases. and further analyse the diagnostic and differential diagnostic value of PET/MR-based multimodal imaging in dysfunctional brain diseases.

Conditions

Brain Disease

Keywords

18F-DPA-714 PET/MR; cognitive impairment; dyskinesia; Disorders of consciousness; Autoimmune encephalitis

Outcome Measures

Primary Outcomes (1)

• Maximum Standardized uptake value (SUVmax)

  1 day from injection of the tracer

Study Arms (1)

Comparative study of different groups

OTHER

This study is planned to include approximately 25 normal volunteers and 40 patients with dysfunctional brain diseases. The screened subjects will undergo multimodal imaging data acquisition using integrated PET/MR (GE Signa). The SUV ratio (SUVR) of each brain region will be obtained using the cerebellum as a reference, and differences in \[18F\]DPA-714 uptake between patients and normal controls will be compared using voxel-based imaging analysis. PCA-based analysis of the distribution pattern of TSPO radioabnormalities in different types of patients. Pearson correlation-based analysis of the correlation between neuroimmune activation and structural and functional parameters.

Diagnostic Test: 18F-DPA-714 PET/MR scan

Interventions

18F-DPA-714 PET/MR scan DIAGNOSTIC_TEST

Saline intravenous solution of 18F-DPA-714 administered at 0.1 mCi/kg by bodyweight

Comparative study of different groups

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dysfunctional disorders diagnosed according to the guidelines include: cognitive disorders, movement disorders, disorders of consciousness-like disorders, and autoimmune encephalitis. Signing the PET/MR informed consent form to volunteer for this study

You may not qualify if:

• Minors, pregnant women, nursing mothers, those with severe liver or kidney insufficiency, history of allergy to contrast media or other drugs. Diagnosis of viral encephalitis, acute myelitis, idiopathic epilepsy, antibody-negative AIE; diagnosis of any major disease; history of alcohol or drug abuse/dependence; history of cardiorespiratory disease, oncology, haematological disorders, poorly controlled chronic diseases; contraindications to PET/MR examination. History of head trauma, history of surgery. History of other neurological disorders.

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Brain Diseases; Cognitive Dysfunction; Dyskinesias; Consciousness Disorders; Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Movement Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Ying Guo Ying Guo

CONTACT

0086+15991459177; guoying01192022@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 28, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share