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OpenTrials
Active, Not Recruiting

NCT Number: NCT04167631

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

MRI Contrast Media Adverse Reaction Bladder Cancer Bladder Cancer Stage Bladder Disease Bladder Neoplasm Bladder Urothelial Carcinoma Carcinoma Diagnoses Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • fungating lesions
  • beyond the scope of enbloc resection

Treatment and study plan

Multi-parametric MRI

Radiation

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

Other names: MP-MRI

Primary outcomes

  1. 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.

    Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 19, 2019
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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