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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04167631
Recruitment Status : Active, not recruiting
First Posted : November 19, 2019
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Mahmoud Laymon, 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).

Condition or disease Intervention/treatment Phase
MRI Contrast Media Adverse Reaction Bladder Cancer Bladder Disease Bladder Neoplasm Bladder Urothelial Carcinoma Bladder Cancer Stage Diagnoses Disease Radiation: Multi-parametric MRI Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020


Arm Intervention/treatment
Multiparametric MRI
Vesical Imaging-Reporting And Data System (VI-RADS) using multi-parametric MRI.
Radiation: Multi-parametric MRI
Vesical Imaging-Reporting And Data System (VI-RADS) for predicting non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI.
Other Name: MP-MRI




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04167631


Locations
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Egypt
Urology and Nephrology Center
Mansoura, Aldakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Ahmed Mosbah, MD Mansoura University
Study Director: Mohammed Aboelghar, MD Mansoura University

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Responsible Party: Mahmoud Laymon, Principal Investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT04167631    
Other Study ID Numbers: MANS.VI-RADS
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahmoud Laymon, Mansoura University:
VI-RADS
Multiparametric MRI
Non-muscle invasive bladder cancer (NMIBC)
Muscle invasive bladder cancer (MIBC)
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urinary Bladder Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type