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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 60 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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. 2. Patients admitted to our hospital for inpatient treatment.

Exclusion Criteria:

1. 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. 2. Patients with persistent seizures or status epilepticus that cannot be controlled by medication, resulting in an inability to cooperate with the examination. 3. patients with poorly controlled blood sugar and ineffective medication intervention. 4. Patients with absolute contraindications for PET/MR examination. 5. Karnofsky Performance Score (KPS) <60.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06092125
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Xuanwu Hospital, Beijing
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jie Lu, Phd
Principal Investigator Affiliation	Xuanwu Hospital of Capital Medical University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Alzheimer Disease, Parkinson Disease, Epilepsy, Malignant Brain Tumor

Additional Details

Calculation of sample size: Conduct research using artificial intelligence on the exact diagnosis and target localization of PET/MR for four different diseases: Alzheimer's disease, Parkinson's disease, epilepsy, and malignant brain tumors. Consequently, the following must be calculated independently from the viewpoints of statistics and picture post-processing modeling, whichever is greater: Referring to the previous studies and the expected sensitivity of this study, the sample sizes were 519, 437, 509, and 509. Considering the 10% loss, data was adjusted to 570, 480, 560 and 560 To meet the requirements, the research will involve 550 cases of epilepsy, 550 cases of Parkinson's disease, 550 cases of Alzheimer's disease, 550 cases of malignant brain tumors, and 100 cases of healthy persons. Data Entry: The researchers will promptly, completely, accurately, and clearly load the data into the case report form, according to the original observation records of the subjects. The questionnaire, reviewed and signed by the supervisor, should be sent to the clinical research data administrator in time. The input is performed using the corresponding electronic database system, involving two people and two machines. Afterward, the database is compared twice. If any issues are discovered during this process, the inspectors are promptly notified, and the researchers are required to provide answers. The exchange of various questions and answers between them should be documented in the form of a questionnaire and kept for future reference. Main Evaluation Indicators: Cases of major brain diseases (Alzheimer's disease, Parkinson's disease, epilepsy, and brain tumors) scanned using domestic and imported PET/MR equipment in a specific year were collected. Clinical diagnosis serves as the gold standard for Alzheimer's disease, Parkinson's disease, and epilepsy cases, while surgical pathology or biopsy results are used as the gold standard for brain tumor cases. The evaluation focuses on the sensitivity (true positive rate) and specificity of PET/MR imaging diagnosis, as well as the accuracy (true negative rate) and precision (rate of correct identification).

Arms & Interventions

Arms

: 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.

: 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.

: 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.

: 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.

Interventions

Device: - PET/MR

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

Contact a Trial Team

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International Sites

Xuanwu hospital, Beijing, Beijing, China

Status

Recruiting

Address

Xuanwu hospital

Beijing, Beijing, 100053

Site Contact

Jie Lu, Phd

[email protected]

+86 13309824318

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