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

Parkinson Disease Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Brain Neoplasms
• Epilepsy
• Malignant Brain Tumor
• Nervous System Diseases
• Parkinson Disease

• NCT number: NCT06092125
• Study type: Observational
• Source: Xuanwu Hospital, Beijing
• Contact: Jie Lu, Phd
• Phone: +86 13309824318
• Email: imaginglu@hotmail.com
• Status: Recruiting
• Start date: February 1, 2023
• Completion date: December 2026