[F-18] Fluciclovine (Axumin) PET/CT vs. [F-18] NaF PET/CT in the Evaluation of Prostate Cancer Osseous Metastatic Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Area under the curve (AUC)
研究概览
简要总结
The purpose of this study is to look at whether F-18 Fluciclovine (i.e. Axumin) is better or as good as F-18 Sodium Fluoride (F-18 NaF) when looking at bone disease from prostate cancer. Axumin is a radioactive agent used on a positron/computed tomography (PET/CT) camera to look for prostate cancer in general.
详细描述
The study will assess the diagnostic performance of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT as the reference standard. Each bone lesion identified on [F-18] NaF PET/CT will be compared with the level of [F-18] fluciclovine uptake
The primary objective is to assess [F-18] fluciclovine efficacy in the evaluation of osseous metastatic disease in prostate cancer on a lesion-by-lesion comparison with [F-18] NaF as a the reference standard.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Referred for initial staging or restaging of prostate cancers with clinical suspicion of bone metastases.
- •Must understand and voluntarily sign an Informed Consent Document
排除标准
- •Cannot tolerate imaging up to 60 minutes of total imaging
结局指标
主要结局
Area under the curve (AUC)
时间窗: At time of scan, up to 60 minutes per scan
Accuracy of \[F-18\] fluciclovine PET/CT compared to \[F-18\] NaF PET/CT evaluated via AUC using Receiver Operating Characteristic (ROC) curves
Number of lesions seen by [F-18] NaF PET/CT which are also seen by [F-18] fluciclovine PET/CT
时间窗: At time of scan, up to 60 minutes per scan
Agreement of imaging methods as measured by number of lesions seen by \[F-18\] NaF PET/CT which are also seen by \[F-18\] fluciclovine PET/CT broken down by diagnostic score on a lesion-by-lesion basis (1 to 5) 1. Definitely benign 2. Probably benign 3. Equivocal 4. Probably malignant 5. Definitely malignant
Sensitivity
时间窗: At time of scan, up to 60 minutes per scan
Accuracy of \[F-18\] fluciclovine PET/CT compared to \[F-18\] NaF PET/CT evaluated via sensitivity Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN): Sensitivity = TP / (TP+FN)
Positive Predictive Value (PPV)
时间窗: At time of scan, up to 60 minutes per scan
Accuracy of \[F-18\] fluciclovine PET/CT compared to \[F-18\] NaF PET/CT evaluated via PPV PPV is the number of true TP divided by the sum of TP and FP: Sensitivity = TP / (TP+FP)
Specificity
时间窗: At time of scan, up to 60 minutes per scan
Accuracy of \[F-18\] fluciclovine PET/CT compared to \[F-18\] NaF PET/CT evaluated via specificity Specificity is the number of true Negatives (TN) divided by the sum of TN and false positives (FP): Sensitivity = TN / (TN+FP)
Negative Predictive Value (NPV)
时间窗: At time of scan, up to 60 minutes per scan
Accuracy of \[F-18\] fluciclovine PET/CT compared to \[F-18\] NaF PET/CT evaluated via NPV NPV is the number of true TN divided by the sum of TN and FN: Sensitivity = TN / (TN+FN)
次要结局
未报告次要终点