An Observational Pilot Study of 18F-Sodium Fluoride (Na18F) Whole Body PET Scans in Patients for Whom 99m Tc MDP Bone Scans Would Normally be Indicated.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 645
- 试验地点
- 7
- 主要终点
- Establish the feasibility of using locally produced 18F-Sodium Fluoride for PET bone scans as a substitute for 99mTc MPD
研究概览
简要总结
This study is being done to provide an alternative to bone scanning with technetium-99m (99mTc) labelled diphosphonates, and to document the safety of {18F}-Sodium Fluoride (Na18F) as a Positron Emission Tomography (PET) imaging radiopharmaceutical. Since the current availability of 99mTc was severely reduced because of the Chalk River shut down, alternative approaches to done scanning are needed. PET imaging with Na18F is one alternative approach to providing this critical clinical service.
详细描述
18F-Sodium Fluoride (Na18F) PET imaging is a nuclear medicine procedure, and its principal radiopharmaceutical, Na18F, has been used for scanning the skeleton for the spread of cancer for more that 30 years, but has not been approved by Health Canada because less expensive alternate drugs have been available (99mTc diphosphonates). Given the sudden and drastic change in the availability of 99mTc, an acceptable alternative for 99mTc-diphosphonates is needed as soon as possible.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 patient for whom 99mTc-MDP bone scans would normally be indicated
- •If female of child-bearing potential and outside the window of 10 days since the last menstrual period, a negative serum or urine pregnancy test is required.
- •Age greater than or equal to 15 years
- •Able and willing to follow instructions and comply with the protocol
- •Provide written informed consent prior to participation in the study
- •If an oncology patient, the patient should have a Karnofsky Performance Scale Score greater than or equal to 50
排除标准
- •Nursing or pregnant females
- •Ages less than 15 years
结局指标
主要结局
Establish the feasibility of using locally produced 18F-Sodium Fluoride for PET bone scans as a substitute for 99mTc MPD
时间窗: 1 year
次要结局
- Demonstrate the safety of 18F-Sodium Fluoride by documentation of adverse events.(1 year)