跳至主要内容
临床试验/NCT04167631
NCT04167631进行中(未招募)不适用

Can Vesical Imaging-Reporting And Data System and Apparent Diffusion Coefficient Values (the VI-RADS/ADC) Accurately Predict Non-Muscle Invasive Bladder Cancer

Mansoura University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150
试验地点
2
主要终点
Vesical Imaging-Reporting And Data System (VI-RADS) for discriminating muscle invasive bladder cancer (MIBC) from non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI.

研究概览

简要总结

Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).

详细描述

Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).

We aim to examine the accuracy of VI-RADS for predicting MIBC in final histopathology specimen. To assess whether incorporating ADC into VI-RADS improves the MIBC predictive accuracy of VI-RADS

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
All
接受健康志愿者

入选标准

  • Patients diagnosed at the out-patient cystoscopy with papillary or small nodular bladder tumour

排除标准

  • fungating lesions
  • beyond the scope of enbloc resection

结局指标

主要结局

Vesical Imaging-Reporting And Data System (VI-RADS) for discriminating muscle invasive bladder cancer (MIBC) from non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI.

时间窗: 18 months

assessed by final histopathology specimen retrieved by enbloc transurethral resection of bladder tumors (ERBT)

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

Mahmoud Laymon

Principal Investigator

Mansoura University

研究点 (2)

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