18F-AV-1451 PET Imaging in Professional Fighters
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Flortaucipir Imaging (Quantitative) Between Fighter Groups
研究概览
简要总结
Subjects enrolled in the Professional Fighters Brain Health Study (PFBHS) will receive flortaucipir to explore its use as a biomarker for brain injury related to repetitive head trauma and to examine the relationship between clinical presentation and tau deposition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All Subjects
- •Currently enrolled in the PFBHS protocol and have participated in a minimum of 10 professional fights
- •Can tolerate Positron Emission Tomography (PET) scan procedures
- •Have the ability to provide informed consent
- •Subjects with cognitive impairment
- •Have subjective cognitive complaints or objective decline or impairment as determined by the investigator
排除标准
- •Have behavior dysfunction that is likely to interfere with imaging
- •Are claustrophobic or otherwise unable to tolerate the imaging procedure
- •Have current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram
- •A history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs that are known to cause QT-prolongation
- •Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- •Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
- •Have current drug or alcohol dependence or alcohol dependence within the past 2 years
研究组 & 干预措施
Active Professional Fighters
Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
干预措施: Flortaucipir F18 (Drug)
Active Professional Fighters
Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
干预措施: Brain PET scan (Procedure)
Retired Professional Fighters
Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
干预措施: Flortaucipir F18 (Drug)
Retired Professional Fighters
Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
干预措施: Brain PET scan (Procedure)
结局指标
主要结局
Flortaucipir Imaging (Quantitative) Between Fighter Groups
时间窗: baseline scan
Standard Uptake Value Ratio (SUVr) by subject enrollment group (active fighter/retired fighter) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Flortaucipir Imaging (Quantitative) Between Cognitive Groups
时间窗: baseline scan
Standard Uptake Value Ratio (SUVr) by subject enrollment group (cognitive impaired/normal) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Flortaucipir Imaging (Qualitative) Between Cognitive Groups
时间窗: baseline scan
Qualitative read results (no, mild, moderate, or intense uptake) compared between cognitively impaired (CI) and cognitively normal (CN) groups.
Flortaucipir Imaging (Qualitative) Between Fighter Groups
时间窗: baseline scan
Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups
次要结局
未报告次要终点