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

Description

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).

Conditions

Urothelial Bladder Cancer, Muscle-Invasive Bladder Cancer

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Study Overview

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Study Details

Study 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).

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

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

Condition
Urothelial Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Orange

Chao Family Comprehensive Cancer Center University of California, Irvine, Orange, California, United States, 92868

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Irvine,

Nataliya Mar, MD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

2030-04