Evaluation of Physician Training for Interpretation of Florbetapir-PET Scans: Validation of Binary Image Rating Methodology Using Amyloid Histopathology at Autopsy as the Reference Standard.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 主要终点
- Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque
研究概览
简要总结
The purpose of this study is re-read of brain amyloid positron emission tomography (PET) scans acquired in previous florbetapir F 18 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had an autopsy to reveal the subject's true amyloid status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Study A07[NCT00857415]):
- •Have a projected life expectancy of ≤ 6 months as determined by the principal investigator (e.g. terminal medical condition) or are already enrolled in a longitudinal study of aging with an autopsy component;
- •Can tolerate a 10 minute PET scan; and
- •Give informed consent for study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die.
排除标准
- •(Study A07[NCT00857415]):
- •Have primary brain tumor, known metastases to the brain, central nervous system (CNS) lymphoma;
- •Have any major, focal structural loss of brain matter;
- •Are aggressively being treated with life sustaining measures (e.g. currently on respirator; receiving high dose chemotherapy);
- •Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive test for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);
- •Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
- •Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, secretase inhibitor);
- •Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
- •Are females of childbearing potential who are pregnant or not using adequate contraception.
结局指标
主要结局
Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque
时间窗: 50-60 min after injection
Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Sensitivity will be calculated as the percent of true positives (as determined by the reference standard, moderate or frequent amyloid plaque at autopsy) that are correctly identified as amyloid positive by the PET scan read. Reported as the median sensitivity of the nine readers.
Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque
时间窗: 50-60 min after injection
Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Specificity will be calculated as the percent of true negatives (as determined by the reference standard, no or sparse amyloid plaque at autopsy) that are correctly identified as amyloid negative by the PET scan read. Reported as the median specificity of the nine readers.
次要结局
- Inter-reader Agreement(50-60 min after injection)