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

NCT ID: NCT04167631

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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

Conditions

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MRI Contrast Media Adverse Reaction Bladder Cancer Bladder Disease Bladder Neoplasm Bladder Urothelial Carcinoma Bladder Cancer Stage Diagnoses Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Multiparametric MRI

Vesical Imaging-Reporting And Data System (VI-RADS) using multi-parametric MRI.

Group Type OTHER

Multi-parametric MRI

Intervention Type RADIATION

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

Interventions

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Multi-parametric MRI

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

Intervention Type RADIATION

Other Intervention Names

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MP-MRI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Laymon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Mosbah, MD

Role: STUDY_CHAIR

Mansoura University

Mohammed Aboelghar, MD

Role: STUDY_DIRECTOR

Mansoura University

Locations

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Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MANS.VI-RADS

Identifier Type: -

Identifier Source: org_study_id

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