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临床试验/NCT02425163
NCT02425163已完成2 期

Shear Wave Elastography of Prostate Cancer

University of Magdeburg2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2012年3月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
73
试验地点
2
主要终点
Shear wave elastography

研究概览

简要总结

Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and Prostate Cancer detection.

详细描述

This Study will evaluate the Shear Wave Elastography (SWE) Parameters for Prostate Biopsy and Prostate Cancer detection.

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

接受健康志愿者

入选标准

  • Suspicious for prostate cancer with no pretreatment and Prostata specific Antigen (PSA) >4ng/ml or PSA velocity > 0.75 ng/ml per year or suspicious transrectal digital examination
  • Status after external beam radiotherapy of the prostate in localized prostate cancer and suspicious for local prostate cancer recurrence

排除标准

  • 未提供

结局指标

主要结局

Shear wave elastography

时间窗: 12 Months

transrectal shear wave elastography with detection of prostate tissue pressure \[kilo-Pascal\] in correspondence to biopsy areas

次要结局

  • Differentiation of Entity by Elastography(12 Months)
  • Differentiation of Prostate cancer malignity by Elastography(12 Months)
  • Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)(12 Months)
  • Histopathological Analysis(12 Months)

研究者

发起方
University of Magdeburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Johann J. Wendler, MD

Dr. med.

University of Magdeburg

研究点 (2)

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