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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Inclusion Criteria:

  • Age 18 years old or greater at the time of consent.
  • Suspected muscle-invasive bladder cancer by tumor appearance on initial routine cystoscopy 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 written informed consent document (prior to the initiation of the study and any study procedures).
  • 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 the Investigator.

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 details
    Urothelial Bladder Cancer
    Muscle-Invasive Bladder Cancer

NCT06335667

University of California, Irvine

28 May 2024

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