Clinical Applicantion of Multi-Tracer PET/MR Imaging in Neurological Disorders/Disease

NCT06092125 | Recruiting DMC FDA Device

• 1 other identifier: Xuanwu[2023]44
• Study Type: observational
• Target: 2,300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the application of domestic PET/MR in major brain diseases. The main questions it aims to answer are:

• Overcome the bottleneck of early accurate diagnosis and treatment in major brain diseases clinical practice.
• Promote the clinical application of domestic PET/MR, enhance international competitiveness. Participants will have a PET/MR scan of the brain.

Conditions

Alzheimer Disease; Parkinson Disease; Epilepsy; Malignant Brain Tumor

Outcome Measures

Primary Outcomes (1)

• SUVr measurement in lesions by 18F-FDG PET images

  1. For AD and PD outcome assessment uses 18F-FDG-PET images for qualitative and quantitative follow-up. The SUVr improvement of 20% or more from baseline is considered a good outcome.An increase in SUVr of less than 20% from the baseline period is considered steady state.Decreased SUVr from baseline was considered a poor outcome 2. For EP and MBT outcome assessment uses 18F-FDG-PET images for qualitative and quantitative follow-up. A reduction in SUVr of more than 70% from baseline period measurements was considered a good outcome. A 50-70% reduction in SUVr from baseline period measurements was considered a stable outcome.A decrease of less than 50% or an increase in SUVr from baseline period measurements was considered a poor outcome.

  3，6，12 month

Other Outcomes (4)

• MMSE score for AD

  3，6，12 month

• UPDRS evaluation for PD

  12 months

• Engle level for EP

  3，6，12 month

Study Arms (4)

Alzheimer's Disease (AD)

The study will collect PET/MR multimodal imaging data, including brain structure, cerebral perfusion, brain function, glucose metabolism, and Aβ deposition, from 100 healthy volunteers, 250 patients with MCI, and 300 patients with AD. Abnormal changes in imaging biomarkers will be analyzed quantitatively, specifically for AD, to determine the specific quantitative threshold for diagnosing AD using 18F-FDG PET and 18F-AV-45 PET and establish imaging biomarkers for early diagnosis of AD. Longitudinal follow-up will be conducted to analyze multimodal imaging data dynamically and discover imaging biomarkers for early prediction of subjective cognitive decline (SCD), MCI, and AD progression.

Device: PET/MR

Parkinson's Disease (PD)

The study aims to collect PET/MR multimodal imaging data from 250 patients with rapid eye movement sleep behavior disorder (RBD) and 300 patients with Parkinson's disease (PD) across multiple centers. The imaging data will include brain structure, brain iron deposition, brain function, glucose metabolism, and vesicular monoamine transporter levels, among other imaging biomarkers. Abnormal changes in these imaging biomarkers will be analyzed quantitatively to determine the specific quantitative threshold for diagnosing PD using 18F-FDG PET and 18F-AV-133 PET and establish imaging biomarkers for early diagnosis of PD. Longitudinal follow-up will be conducted to dynamically analyze the multimodal imaging data and discover imaging biomarkers for early prediction of RBD and PD progression.

Device: PET/MR

Epilepsy(EP)

The study aims to collect PET/MR multimodal imaging data from 550 patients with epilepsy across multiple centers. The imaging data will include brain structure, brain function, glucose metabolism, and microglial cell activity, among other imaging biomarkers, to identify abnormal changes characteristic of epilepsy. Key features will be quantitatively analyzed to determine the specific quantitative threshold for diagnosing epilepsy using 18F-FDG PET and 18F-DPA714 PET and establish imaging biomarkers for epilepsy diagnosis. Using pathological results as the gold standard, the analysis of imaging data from lesions and surrounding brain tissue aims to discover imaging biomarkers that differentiate lesions from normal brain tissue and establish imaging markers for precise localization of epilepsy lesions.

Device: PET/MR

Malignant Brain Tumors(MBT)

A total of 550 patients with malignant brain tumors (gliomas, metastatic tumors, and lymphomas) were collected from multiple centers for PET/MR multimodal imaging of brain structure, brain function, glucose metabolism, and amino acid metabolism, analyzing the characteristic abnormal changes in imaging markers. Using pathological results as the gold standard, specific quantitative threshold values for diagnosing different pathological types of malignant brain tumors using 18F-FDG PET and 18F-FET PET were determined, establishing imaging biomarkers for the diagnosis of malignant brain tumor pathology. Analysis of imaging data of the tumor and surrounding brain tissue revealed imaging markers for distinguishing tumors from surrounding normal brain tissue, enabling precise localization of malignant brain tumors.

Device: PET/MR

Interventions

PET/MR DEVICE

PET/MR device is used for pre-treatment evaluation and efficacy follow-up of four types of diseases

Alzheimer's Disease (AD); Epilepsy(EP); Malignant Brain Tumors(MBT); Parkinson's Disease (PD)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

1. Patients diagnosed with mild cognitive impairment (MCI) or Alzheimer's disease (AD) based on clinical guidelines. 2. Patients diagnosed with rapid eye movement sleep behavior disorder (RBD) or Parkinson's disease (PD) based on clinical guidelines. 3. Patients in accordance with the Chinese guidelines for clinical diagnosis and treatment of epilepsy 4. Patients suspected of malignant brain tumors based on the 2022 Chinese Clinical Guidelines for Gliomas and the 2021 edition of the NCCN Clinical Practice Guidelines in Oncology for Brain Tumors

You may qualify if:

• Patients diagnosed with mild cognitive impairment (MCI) or Alzheimer's disease (AD), rapid eye movement sleep behavior disorder (RBD) or Parkinson's disease (PD), epilepsy, malignant brain tumors based on clinical guidelines.
• Patients admitted to our hospital for inpatient treatment.

You may not qualify if:

• Patients who have undergone non-invasive/minimally invasive treatments such as radiotherapy or chemotherapy within the past three weeks. And Patients who have taken Alzheimer's disease-related and Parkinson's disease-related treatment drugs within the past month.
• Patients with persistent seizures or status epilepticus that cannot be controlled by medication, resulting in an inability to cooperate with the examination.
• patients with poorly controlled blood sugar and ineffective medication intervention.
• Patients with absolute contraindications for PET/MR examination.
• Karnofsky Performance Score (KPS) \<60.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Peking University Cancer Hospital & Institute: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Wuhan TongJi Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• Sun Yat-sen University: collaborator
• Shanghai East Hospital of Tongji University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Xuanwu hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Parkinson Disease; Epilepsy; Brain Neoplasms

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Jie Lu, Phd

  Xuanwu Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Lu, Phd

CONTACT

+86 13309824318; imaginglu@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: October 23, 2023
• Study Start: October 1, 2022
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2028
• Last Updated: July 16, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)