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临床试验/NCT02882958
NCT02882958已完成不适用

Validation of Software-based Fusion of Ultrasound and MRI Images of the Prostate

Massachusetts General Hospital0 个研究点目标入组 30 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
Prostate Volume on Actual MRI

研究概览

简要总结

The investigators hypothesize software-based fusion/navigation will be accurate to within 3 mm of the reference standard of EM fusion. The investigators aim to evaluate the accuracy of prostate US/MRI software-based fusion/navigation technology.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • scheduled for ultrasound-guided gold seeds prostate fiducial placement prior to radiotherapy

排除标准

  • eGFR < 45 mL/min/1.73m2
  • recent (within 4 weeks) kidney or liver transplant
  • contraindication to prostate MRI
  • patient with cardiac pacemaker

结局指标

主要结局

Prostate Volume on Actual MRI

时间窗: Within one month after the fiducial placement

A post-procedure MRI performed within one month after the fiducial placement.

Prostate Volume on US reconstruction

时间窗: During the fiducial placement

A US 3-D sweep will be performed during the fiducial placement.

Prostate Volume based on US/EM reconstruction

时间窗: During the fiducial placement

A 3-D US sweep performed during the fiducial placement and a Electromagnetic tracking data will also be acquired at the same time, and then the two series of data will be used for US/EM reconstruction.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anthony Samir

Associate Director, Ultrasound, Department of Radiology, Massachusetts General Hospital

Massachusetts General Hospital

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