Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Quantification prediction compared with prostate biopsy histology
研究概览
简要总结
With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. CEUS image interpretation is difficult and requires a well-trained expert. To overcome these difficulties CEUS quantification techniques can be of use. The techniques used in this protocol have been developed in cooperation with the Technical University in Eindhoven (TU/e) and BRACCO, Geneva.
The investigators hypothesize improvement of the PCa detection rate with quantification, compared with subjective CEUS interpretation and known numbers in literature.
Also a comparison between quantification results and tumour differentiation grade (Gleason score) will be made, the investigators hypothesize a positive correlation.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SonoVue
Ultrasound Contrast Agent
干预措施: SonoVue (Drug)
结局指标
主要结局
Quantification prediction compared with prostate biopsy histology
时间窗: 3 years
Prostate cancer detection rate by quantification. Answering the question: What is the difference in, for malignancy suspicious, areas between CEUS quantification and subjective interpretation in relation to the histological biopsy results?
次要结局
- Quantification prediction compared with prostate biopsy histology(3 years)
研究者
Prof. dr. ir. H. Wijkstra
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)