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

Last updated: May 17, 2024
Sponsor: University of California, Irvine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urothelial Cancer

Bladder Cancer

Treatment

mpMRI + Diagnostic TURBT

Clinical Study ID

NCT06335667
4565
UCI 23-72
  • Ages > 18
  • All Genders

Study Summary

This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years old or greater at the time of consent.

  • Suspected muscle-invasive bladder cancer by tumor appearance on initial routinecystoscopy as determined by the UCI-affiliated urologist performing this procedure.

  • ECOG Performance Status of 0-3.

  • Patients must have the ability to understand and the willingness to sign a writteninformed consent document (prior to the initiation of the study and any studyprocedures).

  • Patients must be willing and able to comply with the scheduled visits, imaging plan,follow up plan, and other specified study procedures in the opinion of theInvestigator.

Exclusion

Exclusion Criteria:

  • Prior TURBT within 120 days of study entry.

  • Prior therapy for bladder cancer within 120 days of study entry.

  • Inability to tolerate mpMRI or associated contrast.

  • Inability to tolerate TURBT or associated anesthesia.

  • ECOG Performance Status of 4.

  • Female patient who is known to be pregnant or breastfeeding.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: mpMRI + Diagnostic TURBT
Phase:
Study Start date:
March 27, 2024
Estimated Completion Date:
April 30, 2030

Connect with a study center

  • Chao Family Comprehensive Cancer Center University of California, Irvine

    Orange, California 92868
    United States

    Active - Recruiting

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