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

NCT ID: NCT06851143

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Comparative study of different groups

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.

Group Type: OTHER

18F-DPA-714 PET/MR scan

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

18F-DPA-714 PET/MR scan

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ying Guo Ying Guo

Role: CONTACT

guoying01192022@163.com

0086+15991459177

Other Identifiers

KY20252023

Identifier Type: -

Identifier Source: org_study_id