[18F] - FD17 PET Imaging of α-synuclein: A Clinical Study in α-synucleinopathy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- electrocardiogram
研究概览
简要总结
The main objective of this study is to establish a standardized method for [18F] - FD17 PET imaging in α-synucleinopathy patients, and to analyze its physiological distribution in healthy individuals as well as its pathological distribution in α-synucleinopathy patients, including Parkinson's disease (PD), multiple system atrophy (MSA), and idiopathic rapid-eye-movement sleep behavior disorder (iRBD). Specifically, [18F] - FD17 PET imaging focuses on evaluating the deposition of α-synuclein and exploring the diagnostic value of [18F] - FD17 PET in PD, MSA, and iRBD patients. In addition, for PD, MSA and RBD patients, dopamine transporter(DAT)-PET imaging was performed to evaluate the distribution and density of DAT in brain. The study aims not only to clarify the specific binding mode of the imaging agent in different α-synucleinopathies, but also to evaluate its efficacy and potential application prospects in early diagnosis , providing new methods for the diagnosis and treatment of neurodegenerative diseases. This study is expected to contribute to early pathological detection and accurate diagnosis in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1: Normal cognitive function, CDR score=0（for healthy subjects）
- •2: Without neurological disorders, major chronic diseases, malignant tumors, or acute infectious diseases (for healthy subjects）
- •3: Without the family history of neurological disorders related to motor or cognitive impairments(for healthy subjects）
- •4: Clinical diagnosis of idiopathic PD (for PD patients)
- •5: Clinical diagnosis of MSA (for MSA patients)
- •6: Clinical diagnosis of idiopathic RBD (for RBD patients)
- •7: An informed consent form signed in writing by the subject or their legal guardian or caregiver.
- •8: Must be abled to be accompanied by nursing staff
- •9: Must be able to understand and sign a informed consent form before any evaluation and examination
- •10: Must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause for more than one year.(for female subjects)
- •11: Must adopt isolation contraception measures within 3 months after the start of this study.(for female subjects)
- •12: Willing and capable to cooperate with all projects of this study.
排除标准
- •1: Other severe neurological disorders. Gastrointestinal, cardiovascular, liver, kidney, hematological, tumor, endocrine, respiratory, immunodeficiency, and other serious diseases.
- •2: Received ionizing radiation outside the scope of this experiment, resulting in an annual radiation exposure dose exceeding 50 mSv in the past year,
- •3: History of drug abuse or alcoholism
- •4: Pregnant or lactating women
- •5: Poor venous conditions, unable to tolerate repeated venipuncture
- •6: Received experimental drug or device treatment with unclear efficacy or safety in last 1 month.
- •7: Any situation that the investigators believe may cause harm or potential harm in any aspect related to this study
研究组 & 干预措施
PD group
干预措施: PET (Other)
MSA group
干预措施: PET (Other)
RBD group
干预措施: PET (Other)
HC group
干预措施: PET (Other)
结局指标
主要结局
electrocardiogram
时间窗: 2 weeks ahead of and after [18F] - FD17 PET/MRI
Heart rate, atrial rate, ventricular rate, P-R interval, QRS axis, QRS duration, QRS potential, and all other electrocardiographic indicators will be collected by 12-lead electrocardiogram. These outcomes will be used to figure out whether the subjects have a potential heart disease and whether \[18F\] - FD17 PET/MRI will do harm to subjects.
routine blood test
时间窗: 2 weeks ahead of and after [18F] - FD17 PET/MRI
10ml peripheral venous blood will be collected and to measure red blood cell cell count and percentage, hemoglobin content, white blood cell count and percentage, platelet count, and all other indicators in routine blood test. These outcomes will be used to figure out whether the subjects have a potential disease and whether \[18F\] - FD17 PET/MRI will do harm to subjects.
routine urine test
时间窗: 2 weeks ahead of and after [18F] - FD17 PET/MRI
20ml urine will be collected for routine urine test. Indicators including red blood cell and white blood cell count under a microscope, urine specific gravity, urine PH, urinary protein, glucose in urine and all others will be measured. These outcomes will be used to figure out whether the subjects have a potential disease and whether \[18F\] - FD17 PET/MRI will do harm to subjects.
liver renal function test
时间窗: 2 weeks ahead of and after [18F] - FD17 PET/MRI
10ml peripheral venous blood will be collected and to measure alanine aminotransferase(ALT), aspartate aminotransferase(AST), alkaline phosphatase(ALP), Gamma-glutamyltransferase(GGT), creatinine, urea nitrogen, uric acid and all other liver renal function test indicators in serum. These outcomes will be used to figure out whether the subjects have potential hepatorenal dysfunction and whether \[18F\] - FD17 PET/MRI will do harm to subjects.
次要结局
- [18F] - FD17 PET imaging results(Baseline)