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

Primary Purpose

MRI Contrast Media Adverse Reaction, Bladder Cancer, Bladder Disease

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Multi-parametric MRI

Sponsored by

Mansoura University

About this trial

This is an interventional diagnostic trial for MRI Contrast Media Adverse Reaction focused on measuring VI-RADS, Multiparametric MRI, Non-muscle invasive bladder cancer (NMIBC), Muscle invasive bladder cancer (MIBC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Urology and Nephrology Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Multiparametric MRI

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

First Posted

November 15, 2019

Last Updated

November 20, 2019

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT04167631

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

June 1, 2020 (Anticipated)

Study Completion Date

June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

VI-RADS, Multiparametric MRI, Non-muscle invasive bladder cancer (NMIBC), Muscle invasive bladder cancer (MIBC)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Multiparametric MRI

Arm Type

Other

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Multi-parametric MRI

Other Intervention Name(s)

MP-MRI

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Description

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

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Mosbah, MD

Organizational Affiliation

Mansoura University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mohammed Aboelghar, MD

Organizational Affiliation

Mansoura University

Official's Role

Study Director

Facility Information:

Facility Name

Urology and Nephrology Center

City

Mansoura

State/Province

Aldakahlia

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

No

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

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