Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
completion around
Principal Investigator
by Nataliya Mar

Description

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).

Official Title

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

Keywords

Urothelial Bladder Cancer, Muscle-Invasive Bladder Cancer, mpMRI, TURBT, VI-RADS score, Urinary Bladder Neoplasms, mpMRI + Diagnostic TURBT

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Location

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

Lead Scientist at UC Irvine

  • Nataliya Mar
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 27 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT06335667
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated