18F- Sodium Fluoride PET Imaging as a Replacement for Bone Scintigraphy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 10
- 主要终点
- Accuracy, sensitivity, and specificity of 18F-Sodium Fluoride (18F-NaF) Positron Emission Tomography compared to 99mTc-Methylene Diphosphonate (MDP) bone SPECT imaging for detection of bone metastasis.
研究概览
简要总结
The purpose of this study is to compare, in patients with prostate or breast cancer, the accuracy of 18F-NaF PET imaging to 99mTc whole body bone scans with single-photon emission computed tomography (SPECT).
详细描述
Technetium-99m (99mTc) is the most widely used radionuclide in diagnostic nuclear medicine studies. It is used in 20 million diagnostic procedures worldwide annually. It became popular as a radioisotope because of its easy availability from a 99Molybdenum (99Mo)/99mTc generator, historic low costs, and previous high availability.
The National Research Universal (NRU) reactor at Chalk River Laboratories (Ontario, Canada) was shut down unexpectedly in May 2009 following a leak of heavy water. The NRU reactor supplied approximately a third of the world's demand of 99Mo for 99Mo/99mTc generators used diagnostic nuclear medicine tests. Given the fragility of 99Mo supply, alternative radiopharmaceuticals, such as 18F-Sodium Fluoride (18F-NaF), are attractive options to replace 99mTc bone scans. Several studies suggest that 18F-NaF may be more accurate and more sensitive in the detection of bone metastases than 99mTc bone scans.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
18F-NaF PET Imaging for Bone Scintigraphy
All participants will receive PET/CT Imaging using the investigational drug 18F-NaF and a 99mTc-medronate whole body bone scan with SPECT to compare the diagnostic ability of the two methods for the presence of bone metastases.
干预措施: NaF PET/CT Imaging (Procedure)
18F-NaF PET Imaging for Bone Scintigraphy
All participants will receive PET/CT Imaging using the investigational drug 18F-NaF and a 99mTc-medronate whole body bone scan with SPECT to compare the diagnostic ability of the two methods for the presence of bone metastases.
干预措施: 99mTc-medronate whole body bone scan with SPECT (Procedure)
18F-NaF PET Imaging for Bone Scintigraphy
All participants will receive PET/CT Imaging using the investigational drug 18F-NaF and a 99mTc-medronate whole body bone scan with SPECT to compare the diagnostic ability of the two methods for the presence of bone metastases.
干预措施: 18F-Sodium Fluoride (NaF) (Drug)
结局指标
主要结局
Accuracy, sensitivity, and specificity of 18F-Sodium Fluoride (18F-NaF) Positron Emission Tomography compared to 99mTc-Methylene Diphosphonate (MDP) bone SPECT imaging for detection of bone metastasis.
时间窗: At the 24 month post PET/CT follow-up physical examination.
To compare the accuracy, sensitivity, and specificity of 18F-NaF imaging and 99mTc-MDP bone SPECT imaging for bone metastasis detection in patients with breast and prostate cancer.
次要结局
- The secondary outcome is to monitor the short-term side-effects following 18F-NaF PET/CT to assess for adverse drug reactions(Short-term side effects will be monitored for 24 hours following the injection of 18F-NaF (investigational product), and 72 hours following administration of 99mTc-MDP (standard treatment))