Clinical Applicantion of Multi-Tracer PET/MR Imaging in Neurological Disorders/Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,300
- 试验地点
- 1
- 主要终点
- SUVr measurement in lesions by 18F-FDG PET images
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
SUVr measurement in lesions by 18F-FDG PET images
时间窗: 3，6，12 month
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.
次要结局
未报告次要终点