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Completed

NCT Number: NCT07578233

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, 11591, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Magnetic Resonance Imaging

Other

All patients underwent magnetic resonance imaging evaluation.

Primary outcomes

  1. Sensitivity of VI-RADS score for invasion through the bladder wall

    Time frame: 3 months after the procedure

    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).

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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