Validation of VI-RADS for the Detection of Detrusor Muscle Invasion
Primary Purpose
Bladder Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
multi parametric MRI
transurethral resection of bladder tumor
Sponsored by
About this trial
This is an interventional diagnostic trial for Bladder Cancer focused on measuring bladder cancer, MRI ,Vi RADS ,
Eligibility Criteria
Inclusion Criteria:
- • Patients with bladder mass diagnosed by U/S ,CT or MRI and scheduled for cystoscopy
Exclusion Criteria:
• 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.
Sites / Locations
- Ain Shams UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention arm
Arm Description
Patients will undergo MRI followed by TURBT
Outcomes
Primary Outcome Measures
sensitivity and specificity of ViRADS SCORE
Secondary Outcome Measures
Full Information
NCT ID
NCT05123404
First Posted
November 5, 2021
Last Updated
November 5, 2021
Sponsor
Egyptian Biomedical Research Network
Collaborators
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05123404
Brief Title
Validation of VI-RADS for the Detection of Detrusor Muscle Invasion
Official Title
Multiparametric MRI for Bladder Cancer: Validation of VI-RADS for the Detection of Detrusor Muscle Invasion
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Egyptian Biomedical Research Network
Collaborators
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Bladder cancer (BC) is one of the most common and expensive human malignancies to manage. Most BCs are urothelial cell carcinomas (UCCs), and histologically stratified into cancers with low and high grade. The latter are subdivided into those with and without muscle invasion.(1) Non-muscle-invasive BCs (NMIBCs) are often low grade and have an indolent natural history. Muscle-invasive BCs (MIBCs) are aggressive tumors with an ominous prognosis. (2) Non-muscle invasive bladder cancer is treated with transurethral resection of bladder tumor with or without adjuvant intravesical chemotherapy or photodynamic therapy, whereas muscle-invasive bladder cancer is treated with radical cystectomy, radiation therapy, chemotherapy, or a combination(3).
Bladder cancer staging is accomplished by the combination of clinical (examination), pathologic (transurethral resection of bladder tumor specimens), and radiologic means. The quality of the transurethral resection of bladder tumors often varies among surgeons, and it may miss muscle infiltration in up to 25% of invasive cancers. (4) Radiological examination looks for second urinary tract malignancies (5% of BCs may have an upper tract UCC) or other pathologies. Most guidelines suggest cross-sectional imaging for MIBCs and high-grade NMI cancers, due to the risks of invasion and regional or distant metastases, and upper urinary tract involvement. (5) MRI is currently the best imaging technique for bladder cancer local regional staging because of its superior soft tissue contrast, lack of ionizing radiation, in addition, it clearly differentiates the layer of bladder wall and enables accurate assessment of tumor depth invasion in bladder wall and extra-vesical extension. (6) During the past few years, important improvements in MRI technology have been achieved and led to the introduction of Multiparametric MRI (mp MRI) which combines functional sequences as diffusion weighted imaging (DWI) and dynamic contrast enhanced MRI (DCE-MR) with anatomic T1 and T2 weighted images (T1 and T2WI), that improves the accuracy of tumor detection and staging, helps to monitor post-therapy response and identify local disease recurrence. (7) Recently also standardized approach for imaging and reporting mp-MRI for bladder cancer was created by developing VI-RADS score (Vesical Imaging Reporting and Data System). This aims to standardize bladder mpMRI for clinical and research applications to create a systematic approach for reporting bladder mp-MRI and defining the risk of muscle invasion (NMIBC versus MIBC). (8) The Final VI-RADS score is generated using all categories and suggests the probability of muscle invasion ,It's graded from VIRADS 1 (muscle invasion is highly unlikely) to VI-RADS 5 (ivasion of muscle and beyond the bladder is very likely) (9) 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.
2- AIM:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
bladder cancer, MRI ,Vi RADS ,
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention arm
Arm Type
Experimental
Arm Description
Patients will undergo MRI followed by TURBT
Intervention Type
Diagnostic Test
Intervention Name(s)
multi parametric MRI
Intervention Description
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 Type
Procedure
Intervention Name(s)
transurethral resection of bladder tumor
Intervention Description
detection of degree of invasion to test accuracy of ViRADS score
Primary Outcome Measure Information:
Title
sensitivity and specificity of ViRADS SCORE
Time Frame
4 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Patients with bladder mass diagnosed by U/S ,CT or MRI and scheduled for cystoscopy
Exclusion Criteria:
• 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed Tawfeek, ass. Professor
Phone
+201005664873
Email
drahmedtawfeek@med.asu.edu.eg
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
eslam mohamed
12. IPD Sharing Statement
Plan to Share IPD
No
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Validation of VI-RADS for the Detection of Detrusor Muscle Invasion
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