跳至主要内容
临床试验/NCT06337591
NCT06337591已完成不适用

Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location

Istituto Nazionale di Ricovero e Cura per Anziani3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
3
主要终点
Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection

研究概览

简要总结

VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.

详细描述

The VI-RADS (bladder imaging-reporting and data system) scoring system is an imaging tool that can help distinguish non-muscle-invasive from muscle-invasive disease prior to transurethral resection (TURB). The VI-RADS consists of a five-point scoring system based on the assessment of tumour size, morphology, growth, degree of restriction and contrast capture to assess the likelihood of bladder wall invasion. VI-RADS was an observational, prospective, multicenter, no profit study. The aims of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with suspected primary bladder cancer at cystoscopy

排除标准

  • Impaired renal function
  • claustrophobia
  • allergy to paramagnetic contrast agent

结局指标

主要结局

Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection

时间窗: up to 12 weeks

The sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in muscle invasion will be evaluated by comparing the score of VI-RADS with the results of biopsy after transurethral resection of bladder cancer.

次要结局

未报告次要终点

研究者

发起方
Istituto Nazionale di Ricovero e Cura per Anziani
申办方类型
Other
责任方
Sponsor

研究点 (3)

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