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mpMRI vs TURBT for Bladder Cancer

N/A
Recruiting
Led By Nataliya Mar, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial aims to confirm how well a scoring system called VI-RADS, obtained through a specific type of MRI scan, matches up with the cancer stage found during a bladder tumor removal surgery. It will

Who is the study for?
This trial is for adults over 18 with suspected muscle-invasive bladder cancer, as seen in initial cystoscopy. Participants must be able to undergo MRI and TURBT procedures, have an ECOG Performance Status of 0-3, and be willing to follow the study plan. Pregnant or breastfeeding women, those who've had prior bladder cancer therapy or TURBT within the last 120 days, or cannot tolerate MRI contrast are excluded.
What is being tested?
The study tests how well a multi-parametric magnetic resonance imaging (mpMRI) can predict bladder cancer stage compared to the standard diagnostic method called transurethral resection of bladder tumor (TURBT). It's a single-arm pilot study that also looks at patient outcomes and quality of life following these diagnostic techniques.
What are the potential side effects?
Potential side effects may include discomfort from the mpMRI procedure or reactions to its contrast agent. The TURBT process might cause typical surgical risks such as bleeding, infection, pain during recovery, and complications related to anesthesia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of concordance between VI-RADS score of 4 or 5 (i.e. muscular propria is likely or very likely) on mpMRI and pathologic muscularis propria invasion (i.e. pT2 tumor stage) on diagnostic TURBT.
Secondary outcome measures
Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT
Patient Quality of Life with mpMRI versus diagnostic TURBT.
Progression free survival (PFS) with mpMRI compared to diagnostic TURBT

Trial Design

1Treatment groups
Experimental Treatment
Group I: mpMRI + Diagnostic TURBTExperimental Treatment1 Intervention

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Who is running the clinical trial?

University of California, IrvineLead Sponsor
559 Previous Clinical Trials
1,929,978 Total Patients Enrolled
Nataliya Mar, MDPrincipal InvestigatorChao Family Comprehensive Cancer Center
~15 spots leftby Apr 2025
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