Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Rate of Correlation Between Ultrasound Results and Pathology Results
研究概览
简要总结
The main purpose of this study is to determine the accuracy and feasibility (possibility) of Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.) for detecting prostate cancer in men undergoing radical prostatectomy.
详细描述
The point estimate and its 95% confidence interval will be calculated using the exact binominal method. Identification of suspicious cancer tissue in a 12 prostate zone schema: Participants will undergo USE: Aixplorer® ShearWave Elastography (SWE™), (SuperSonic Imagine). Areas of the prostate with high suspicion for harboring cancer will be recorded in a 12 zone prostate schema. For study purposes the prostate will be divided into Zone 1(Left Lateral Base), Zone 2 (Left Base), Zone 3 (Right Base), Zone 4 (Right Lateral Base), Zone 5 (Left Lateral Mid), Zone 6 (Left Mid), Zone 7 (Right Mide), Zone 8 (Right Lateral Mid), Zone 9 (Left Lateral Apex), Zone 10 (Left Apex), Zone 11 (Right Apex), Zone 12 (Right Lateral Apex).
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
- •Men with prostate cancer who elect surgery as the primary treatment of their cancer and to be performed at the Moffitt Cancer Center.
- •Biopsy confirmed prostate cancer with at least ten biopsies performed for diagnosis.
- •Location of cancer specified in the pathology report.
- •Pathology reviewed by Moffitt pathologist
排除标准
- •Less than ten biopsies obtained at time of diagnosis.
- •Location of cancer not specified.
- •Pathology not reviewed by Moffitt pathologist.
结局指标
主要结局
Rate of Correlation Between Ultrasound Results and Pathology Results
时间窗: 6 months
Investigators will correlate the pathology findings from the radical prostatectomy specimen with the data recorded from USE.
次要结局
未报告次要终点