18F-Fluoride PET Bone Scans Versus Traditional 99mTc-MDP Gamma Camera Bone Scans for the Diagnosis of Bone Metastases: a Blinded, Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- Accurate identification of bone metastases
研究概览
简要总结
The purpose of this study is to compare 18F-Fluoride PET bone scans to traditional 99mTc-MDP bone scan to determine if one is better for diagnosing bone metastases.
详细描述
Compare the diagnostic sensitivity, specificity, and accuracy of 18F-Fluoride PET bone scans versus traditional 99mTc-MDP bone scans for detecting bone metastases.
Determine if there is a significant change in clinical management between the two types of scans.
Measure and compare the number of equivocal or uncertain findings that would have caused additional testing, particularly additional imaging studies, to be performed for confirmation when using 18F-Fluoride PET bone scans versus 99mTc-MDP bone scans.
To quantify any adverse events resulting from either scan.
To perform subgroup analyses according to cancer cell type.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has cancer
- •Has been referred for evaluation of bone metastases
- •Patient or patient's legal representative can understand and consent to enrollment in the study
- •Must be 18 years or older
- •Can remain still during the scan (approximately one hour)
- •Patient has Medicare
排除标准
- •Patient does not have Medicare
- •Under the age of 18
- •Cannot lie still for the necessary time
结局指标
主要结局
Accurate identification of bone metastases
时间窗: Upon study completion (2-3 years)
Individual subjects will be reviewed 6-12 months after their bone scans, utilizing all clinical and imaging data available, to determine diagnostic accuracy of each bone scan.
次要结局
- Change in clinical management(Upon study completion (2-3 years))
- Determine if F-18 PET bone scans lead to fewer follow-up imaging studies.(Upon study completion (2-3 years))
- Quantify any adverse events from either type of scan.(Upon study completion (2-3 years))
- Perform subgroup analyses according to cancer cell type.(Upon study completion (2-3 years))
研究者
David Djang
Nuclear medicine physician
Seattle Nuclear Medicine