Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner
研究概览
简要总结
This clinical trial studies an ultrasound-based imaging procedure called elastography using the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet known whether elastography imaging using the Aixplorer system works better than standard ultrasound imaging in detecting prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the detection of prostate cancer with elastography using the Aixplorer scanner.
SECONDARY OBJECTIVES:
I. To obtain quantitative data on the elastic properties of normal and malignant tissue in the prostate of patients referred for ultrasound guided biopsy.
II. To compare the Gleason grade of prostate cancers detected with elastography to the Gleason grade of tumors detected by conventional systematic biopsy.
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
- •Be scheduled for a clinically indicated biopsy of the prostate
- •Agree to an ultrasound examination using the Aixplorer system
- •Sign an institutional review board (IRB) approved informed consent prior to any study procedures
排除标准
- •Recent prostate biopsy within 90 days
结局指标
主要结局
Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner
时间窗: At the time of prostate biopsy
Will focus on comparing the frequency of diagnosis of prostate cancer between conventional systematic biopsy and targeted biopsy based upon abnormalities in gray scale imaging, Doppler imaging, and elastography. The main parameter of interest will be the ratio of the detection frequency with targeted biopsy versus that with systematic biopsy. The analyses will be based on methods for matched data in cohort studies and will use the appropriate estimate and variance for the relative risk.
次要结局
- Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy(At the time of prostate biopsy)