Validation of VI-RADS for the Detection of Detrusor Muscle Invasion

NCT05123404 | Unknown

• 1 other identifier: FMASU MS293/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the accuracy of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer using vesical imaging reporting and data system (VI-RADS) score.

Conditions

Bladder Cancer

Keywords

bladder cancer, MRI ,Vi RADS ,

Outcome Measures

Primary Outcomes (1)

• sensitivity and specificity of ViRADS SCORE

  4 months

Study Arms (1)

intervention arm

EXPERIMENTAL

Patients will undergo MRI followed by TURBT

Diagnostic Test: multi parametric MRI; Procedure: transurethral resection of bladder tumor

Interventions

multi parametric MRI DIAGNOSTIC_TEST

In our study we aim to evaluate role of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer and accuracy of vesical imaging reporting and data system (VI-RADS) score.

intervention arm

transurethral resection of bladder tumor PROCEDURE

detection of degree of invasion to test accuracy of ViRADS score

intervention arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with bladder mass diagnosed by U/S ,CT or MRI and scheduled for cystoscopy

You may not qualify if:

• Patients with general contraindication for MRI examination (as metallic prosthesis, pacemaker or claustrophobia).
• Patients with contraindication for transurethral resection (TUR) (as those unfit for anesthesia).
• Patients with high renal functions, as they are contraindicated for dynamic contrast enhancing imaging.
• Patients there histopathology proved that their bladder mass not TCC.

Sponsors & Collaborators

• Egyptian Biomedical Research Network: lead
• Ain Shams University: collaborator

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging; Transurethral Resection of Bladder

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

ahmed Tawfeek, ass. Professor

CONTACT

+201005664873; drahmedtawfeek@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 17, 2021
• Study Start: November 4, 2021
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)