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

NCT07578233 | Completed

• 1 other identifier: FMASU MS 293a/2021/2024
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiparametric; Magnetic Resonance Imaging; Validation; Vesical Imaging Reporting and Data System (VI-RADS); Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study group

Patients with bladder masses diagnosed through ultrasound, computed tomography, or magnetic resonance imaging, who were scheduled for cystoscopy

Other: Magnetic resonance imaging

Interventions

Magnetic resonance imaging OTHER

All patients underwent magnetic resonance imaging evaluation.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology, Ain Shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: August 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)