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NCT04167631 Clinical Trial

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

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04167631
Other study ID # MANS.VI-RADS
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date January 1, 2024

Study information
Verified date October 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date January 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Urology and Nephrology Center Mansoura Aldakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. assessed by final histopathology specimen retrieved by enbloc transurethral resection of bladder tumors (ERBT) 18 months
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