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临床试验/NCT03418207
NCT03418207Unknown不适用

The Study on the Spatial Distribution of Prostate Cancer by Modified Trans-perineal Template-guided Mapping Biopsy

Subei People's Hospital of Jiangsu Province1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
the spatial distribution based on the biopsy tissue

研究概览

简要总结

Investigators plan to use modified TTMB technology to puncture prostate of participants suspected prostate cancer, especially those with the first negative biopsy , but having a rising PSA.Then, Investigators will simulate the spatial distribution of prostate cancer in patients with positive biopsy before radical prostatectomy by way of the TPS software system . And after the radical prostatectomy ,Investigators will simulate the spatial distribution with the help of large tissue slice technique to compare with preoperative simulation ,which to verify the two simulations are consistent.

详细描述

Investigators mainly plan to determine the accuracy of the modified TTMB technology in combination with the TPS system on the location of the tumor space distribution by comparing the two simulation, which is significant for the accurate focal thearpy.

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 90 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 1.Male patients;
  • 2.18 yrs and older, and 90 yrs and younger;
  • 3.Rectal examination reveal prostate nodules;
  • 4.B ultrasound, CT or MRI find abnormal images;
  • 5.PSA>4ng/ml, abnormal f/t ratio and PSAD

排除标准

  • Abnormal coagulation function;
  • Severe urinary tract infection;
  • Serious cardiovascular and cerebrovascular disease

结局指标

主要结局

the spatial distribution based on the biopsy tissue

时间窗: 2 years

to simulate the spatial distribution of cancer based on the biopsy tissue contained cancer with the help of TPS system

次要结局

  • the spatial distribution based on the large tissue slice technique(2 years)

研究者

发起方
Subei People's Hospital of Jiangsu Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xuefei Ding,MD

Chief physician of urology

Subei People's Hospital of Jiangsu Province

研究点 (1)

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