Study on the Application of ¹⁸F-FCOB04, a MAO-B Targeted PET Imaging Agent, in Neurodegenerative Diseases
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Regional standardized uptake value ratio (SUVR) on 18F-FCOB04 PET
研究概览
简要总结
In this clinical trial, we intend to perform 18F-FCOB04 PET imaging in patients with neurodegenerative diseases to observe the brain uptake of this tracer.We will investigate the distinct imaging patterns of brain MAO-B expression in patients with various neurodegenerative diseases.Correlation analysis will be conducted between imaging findings and relevant clinical indicators.This study aims to evaluate the role of 18F-FCOB04 in the auxiliary diagnosis of neurodegenerative diseases, as well as to assess the tolerability and safety of the tracer and the imaging procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 75 years, regardless of gender.
- •Patients diagnosed with probable or possible neurodegenerative diseases by a specialist neurologist according to current internationally recognized clinical diagnostic criteria, including but not limited to Alzheimer's disease, Parkinson's disease, and Parkinsonian syndromes (such as progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, etc.).Diagnosis is based on a comprehensive evaluation including systematic medical history collection, neurological examination, relevant neuropsychological or motor function scale assessments, combined with conventional structural neuroimaging such as cranial MRI.Patients with a history of brain surgery, brain cyst, brain tumor, or other comorbidities that may affect data analysis are excluded.
- •Prior to any assessment, the subject or their legal representative has understood and signed the written informed consent form.
- •Subjects who are currently using, or have not used MAO-B inhibitors (including but not limited to selegiline, rasagiline, safinamide) for ≥14 days prior to enrollment.
排除标准
- •Suffering from other severe neurological diseases, or severe diseases of the gastrointestinal, cardiovascular, hepatic, renal, hematological, oncological, endocrine, respiratory, immunodeficiency or other severe systemic disorders.
- •Suffering from claustrophobia.
- •History of substance abuse or excessive alcohol consumption.
- •Female subjects who are pregnant or breastfeeding.
- •Presence of any condition that, in the opinion of the investigator, may be harmful or potentially harmful to the subject in any procedure related to this study.
研究组 & 干预措施
Patients（Experimental）
Patients with neurodegenerative diseases will receive a single intravenous injection of the investigational PET tracer 18F-FCOB04 followed by PET/CT imaging for evaluation of biodistribution and lesion uptake.
干预措施: 18F-FCOB04 (Drug)
Healthy Volunteers
Healthy participants will receive a single intravenous injection of the investigational PET tracer 18F-FCOB04 followed by PET/CT imaging for safety and dosimetry assessment.
干预措施: 18F-FCOB04 (Drug)
结局指标
主要结局
Regional standardized uptake value ratio (SUVR) on 18F-FCOB04 PET
时间窗: Baseline (Day 1, at the time of 18F-FCOB04 PET imaging)
Regional standardized uptake value ratio (SUVR) measured on 18F-FCOB04 positron emission tomography (PET) images. SUVR is defined as the ratio of tracer uptake in a predefined target brain region to uptake in a predefined reference region. The measurement unit is unitless. SUVR will be calculated using PET image analysis software based on predefined regions of interest.
次要结局
未报告次要终点