Multiparametric MRI for Bladder Cancer: Validation of VI-RADS for the Detection of Muscle Invasive Bladder Cancer

This research aimed to determine how accurately multiparametric magnetic resonance imaging (MRI), when interpreted using the VI-RADS scoring system, can distinguish between invasive and non-invasive bladder cancer.

Study Overview

• Status: Completed
• Conditions: Magnetic Resonance Imaging; Muscle Invasive Bladder Cancer; Validation; Multiparametric; Vesical Imaging Reporting and Data System (VI-RADS)
• Intervention / Treatment: Other: Magnetic resonance imaging

Detailed Description

Bladder cancer (BC) is among the most widespread malignancies needing management. The majority of bladder cancers are urothelial cell carcinomas, which are further classified histologically into low-grade and high-grade categories.

Multiparametric magnetic resonance imaging (mpMRI), a recent advancement in MRI technology, combines functional sequences like DWI and DCE-MRI with anatomical T1- and T2-weighted images. This integrated approach enhances tumor detection and staging accuracy, aids in post-therapy response monitoring, and facilitates the identification of local disease recurrence.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This cross-sectional study involved 60 patients with bladder masses diagnosed through ultrasound, computed tomography, or magnetic resonance imaging (MRI), who were scheduled for cystoscopy. The study was carried out with approval from the Ethical Committee at our institute. Informed written consent was obtained from all participants.

Description

Inclusion Criteria:

• Both sexes.
• Patients with bladder masses diagnosed through ultrasound, computed tomography, or magnetic resonance imaging (MRI), who were scheduled for cystoscopy.

Exclusion Criteria:

• Contraindications to MRI (such as metallic prostheses or pacemakers).
• Contraindications to Transurethral Resection (like unfitness for anesthesia or urethral strictures).
• Elevated serum creatinine levels (precluding IV contrast-enhanced imaging).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Patients with bladder masses diagnosed through ultrasound, computed tomography, or magnetic resonance imaging, who were scheduled for cystoscopy	Other: Magnetic resonance imaging; All patients underwent magnetic resonance imaging evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of VI-RADS score for invasion through the bladder wall	Sensitivity of VI-RADS score for invasion through the bladder wall was recorded. At the end VI-RADS scoring was calculated using all categories, to know the probability of muscle invasion as follows: VI-RADS 1 (very low probability of muscle invasion ): SC, CE, and DW category 1; VI-RADS 2 (low probability of muscle invasion): SC, CE, and DW category 2; both CE and DW category 2 with SC category 3; VI-RADS 3 (muscle invasion is equivocal): SC, CE, and DW category 3; SC category 3 and CE or DW category 3, with the remaining sequence in category 2; (Category 3 should be applied when category 2 findings are absent in their respective sequences but there is no apparent disruption of the typical SI in the muscularis propria, there may be Misclassifications in the VI-RADS 2-3 group).	3 months after the procedure

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy
• Other Study ID Numbers: FMASU MS 293a/2021/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No