Can VI-RADS/ADC Accurately Stage Bladder Cancer??

Not Applicable

Active, not recruiting

• Conditions: Bladder Cancer; Bladder Urothelial Carcinoma; MRI Contrast Media Adverse Reaction; Bladder Cancer Stage; Diagnoses Disease; Bladder Disease; Bladder Neoplasm
• Interventions: Radiation: Multi-parametric MRI

• Registration Number: NCT04167631
• Lead Sponsor: Mansoura University

Brief Summary

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).

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2024-12-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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Exclusion Criteria

• fungating lesions
• beyond the scope of enbloc resection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multiparametric MRI	Multi-parametric MRI	Vesical Imaging-Reporting And Data System (VI-RADS) using multi-parametric MRI.

Primary Outcome Measures

Name	Time	Method
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.	18 months	assessed by final histopathology specimen retrieved by enbloc transurethral resection of bladder tumors (ERBT)

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Aldakahlia, Egypt