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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2028-10-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Alzheimer Disease Parkinson Disease Epilepsy Malignant Brain Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.