A Phase I/II, Phase III and Extended Phase III Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Cancer or Suspected Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10,838
- 试验地点
- 1
- 主要终点
- To demonstrate the safety of 18F-FDG synthesized from cyclotron produced radiofluoride in the Coincidence Technologies automated synthesis unit (ASU) in the Edmonton PET Centre facility
研究概览
简要总结
Positron Emission Tomography (PET) is a specialised nuclear medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity. The most common of these radiolabeled tracers is 18F-fluorodeoxyglucose (18F-FDG), which is used to determine abnormal glucose metabolism in tumours and other sites. It has general applications in all areas where abnormal glucose metabolism may be present including in circumstances such as differentiating the tumour from scar tissue; evaluating the presence of the tumour in light of rising tumour markers and normal morphological imaging techniques; and assessing response to therapy where other techniques are deemed to be unhelpful. The Cross Cancer Institute (CCI) has recently been funded to establish a PET centre, and this study will prove the effectiveness of PET scanning in the Canadian health care environment and validate the data that have been developed in other jurisdictions in specific oncologic indications.
详细描述
Background
Positron Emission Tomography (PET) is a specialised Nuclear Medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity. The commonest of these radiolabeled tracers is 18F-Fluorodeoxyglucose (18F-FDG), which is used to determine abnormal glucose metabolism in tumours and other sites. It has general applications in all areas where abnormal glucose metabolism may be present including circumstances such as differentiating tumour from scar tissue, evaluating the presence of tumour in the light of rising tumour markers and normal morphological imaging techniques and assessing response to therapy where other techniques are deemed to be unhelpful.
The Cross Cancer Institute has recently been funded to establish a PET centre that will establish a research programme to prove the effectiveness of PET scanning in the Canadian health care environment and validate the data that have been developed in other jurisdictions in specific oncologic indications.
Objectives
Primary Objectives - The objectives of the clinical trial are to (a) demonstrate the safety of 18F-FDG synthesised from cyclotron produced radiofluoride in the Coincidence Technologies automated synthesis unit (ASU) in the Edmonton PET Centre facility and (b) confirm the diagnostic effectiveness of 18F-FDG in subjects with known or suspected oncologic disease and to compare this with values published in the literature.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female. (If female of child-bearing potential and outside of the window of 10 days since the last menstrual period, a negative serum or urine pregnancy test is required.)
- •Known or suspected primary or metastatic tumours
- •Age equal to or greater than 15 years
- •Able and willing to follow instructions and comply with the protocol
- •Provide written informed consent prior to participation in this study
- •Karnofsky Performance Scale score 60-100
排除标准
- •Nursing or pregnant females
- •Presence of a severe infection
- •Age less than 15 years
- •Having had surgery or radiotherapy within 10 days of the planned imaging study
结局指标
主要结局
To demonstrate the safety of 18F-FDG synthesized from cyclotron produced radiofluoride in the Coincidence Technologies automated synthesis unit (ASU) in the Edmonton PET Centre facility
时间窗: One Year
次要结局
- To confirm the diagnostic effectiveness of 18F-FDG in subjects with known or suspected oncologic disease and compare this to literature values(One Year)