18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology
试验速览
- 阶段
- 3 期
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- To confirm the diagnostic effectiveness of 18F-Fluorodeoxyglucose(FDG) as compared to the gold standard of histopathological diagnosis.
研究概览
简要总结
This clinical trial is being conducted to study the use of a radioactive glucose tracer as an imaging test [Positron Emission Tomography (PET)scan] in adults who have or are suspected of having cancer and in another group of adults to assess for neurologic conditions.
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
- None
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
- •Known or suspected primary or metastatic tumours
- •A neurological presentation consistent with the list of indications
- •18 years of age or older of either sex
- •Able to provide written informed consent
- •Able to tolerate the physical and logistical requirements of completing a Positron Emission Tomography (PET)scan
- •Karnofsky score > 60
- •Women who are nursing may be included in the study if they are able to discontinue breast feeding for 12 hours
排除标准
- •Age <18 years
- •Pregnant women; if there is a possibility of pregnancy, bloodwork will be drawn to definitively establish pregnancy status
- •Women who are unwilling or unable to discontinue breast feeding for 12 hours post 18F-Fluorodeoxyglucose(FDG) administration
- •Subjects who are medically unstable
- •Subjects unwilling to provide informed consent.
- •Subjects who exceed the safe weight limit of the Positron Emission Tomography (PET) imaging bed or who cannot fit through the PET scanner bore
结局指标
主要结局
To confirm the diagnostic effectiveness of 18F-Fluorodeoxyglucose(FDG) as compared to the gold standard of histopathological diagnosis.
时间窗: Three years
The primary outcomes of sensitivity and accuracy of 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) studies will be obtained by comparing results of the PET scan with the gold standard of histopathological diagnosis when those results are available. Comparison to correlative imaging follow-up, and assessment of efficacy based on feedback from referring physicians will be used in the absence of pathologic data.
次要结局
未报告次要终点