Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06335667

Outcomes With Multi Parametric MRI (mpMRI) Compared to Diagnostic Transurethral Resection of Bladder Tumor (TURBT) in Patients With Suspected Muscle-Invasive Bladder Cancer - a Pilot Study

Led by University of California, Irvine · Updated on 2026-05-04

30

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the accuracy of the VI-RADS score from multi-parametric magnetic resonance imaging (mpMRI) compared to the pathology results from diagnostic transurethral bladder tumor resection (TURBT) in patients suspected of having muscle-invasive bladder cancer. This pilot, single-arm, prospective study also compares clinical outcomes and quality of life between these two diagnostic methods. The goal is to understand how well mpMRI can detect muscle invasion in bladder cancer compared to the current standard TURBT procedure. Participants will undergo both mpMRI and the TURBT surgical procedure as part of the study. The mpMRI will provide a VI-RADS score indicating the likelihood of muscle invasion, and TURBT will provide pathological staging. This combined diagnostic approach allows researchers to compare imaging results directly to tissue pathology. The study will monitor patients for up to five years to evaluate progression-free survival, adverse events, quality of life, repeat surgeries, and healthcare costs related to each diagnostic method. During the study, participants will have scheduled visits for imaging, surgery, and follow-up assessments. Researchers will collect data on cancer progression, timing of treatments, and patient quality of life over time. They will also track any complications or additional procedures needed. The primary outcome is whether the mpMRI VI-RADS score matches the pathological muscle invasion found by TURBT within one year. Secondary outcomes include long-term cancer outcomes, safety, quality of life, and healthcare expenditures over up to five years.

CONDITIONS

Brief Title

mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years old or greater at the time of consent
  • Suspected muscle-invasive bladder cancer by tumor appearance on initial routine cystoscopy
  • ECOG Performance Status of 0 to 3
  • Ability and willingness to sign informed consent
  • Willing and able to comply with scheduled visits, imaging, follow-up, and study procedures
Not Eligible

You will not qualify if you...

  • Prior TURBT within 120 days before study entry
  • Prior therapy for bladder cancer within 180 days before study entry
  • Inability to tolerate mpMRI or contrast
  • Inability to tolerate TURBT or associated anesthesia
  • ECOG Performance Status of 4
  • Female who is pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single assessment period

Participants undergo multiparametric MRI (mpMRI) and diagnostic transurethral resection of bladder tumor (TURBT) to assess for muscle-invasive bladder cancer.

1 visit for mpMRI and TURBT procedure

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for progression-free survival, adverse events, quality of life, and other outcomes up to 5 years after diagnostic evaluation.

Follow-up visits as per routine care up to 5 years

Trial Site Locations

Total: 1 location

1

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, United States, 92868

Actively Recruiting

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Research Team

C

Chao Family Comprehensive Cancer Center University of California, Irvine

U

University of California Irvine Medical

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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