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临床试验/NCT02939456
NCT02939456已完成不适用

Comparison Of Double Inversion Recovery Magnetic Resonance Imaging (Dir-Mri) And Dynamic Contrast Enhanced Magnetic Imaging (Dce-Mri) In Detection Of Prostate Cancer: A Pilot Study

University Hospitals of North Midlands NHS Trust2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Lesion to Normal tissue Ratio (LNR) recorded for DIR-MRI and DCE-MRI

研究概览

简要总结

This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI).

Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team.

详细描述

This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI). Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team. The research team will look at the variability of LNR score amongst the two scan typed and the DCE-MRI and DIR-MRI images will be correlated with biopsy results to give an indication of the accuracy.

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
Female
接受健康志愿者

入选标准

  • Patients referred for prostate MRI for possible prostate cancer
  • Safe to undergo an MRI scan
  • Able to give informed consent

排除标准

  • MRI referrals where prostate cancer is not the question
  • Patients who are not safe to undergo an MRI scan
  • Patients who have undergone prostate biopsy in the previous 10 weeks
  • Patients unable to give informed consent

研究组 & 干预措施

DIR-MRI

Other

Participants will have Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) as well as the standard Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)

干预措施: Magnetic Resonance Imaging (Other)

结局指标

主要结局

Lesion to Normal tissue Ratio (LNR) recorded for DIR-MRI and DCE-MRI

时间窗: 3 months

In order to inform a sample size calculation for a subsequent, fully powered equivalence trial Is DIR-MRI equivalent to DCE-MRI in detection of prostate cancer

次要结局

  • Correlation of biopsy and DIR-MRI and DCE-MRI findings(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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