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

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

INTRODUCTION

  • Org Study ID: 4565
  • Secondary ID: N/A
  • NCT ID: NCT06335667
  • Sponsor: University of California, Irvine

BRIEF 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).

  • Overall Status
    Recruiting
  • Start Date
    March 27, 2024
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Urothelial Bladder Cancer
  • Muscle-Invasive Bladder Cancer

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Nataliya Mar, MD

Role: Principal Investigator

Affiliation: Chao Family Comprehensive Cancer Center

Overall Contact

Name: Chao Family Comprehensive Cancer Center University of California, Irvine, University of California Irvine Medical

Phone: 1-877-827-8839

Email: ucstudy@uci.edu, marn@hs.uci.edu

LOCATION

Facility Status Contact
Facility: Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California 92868
United States
Status: Recruiting Contact: Contact
Nataliya Mar, MD
877-827-8839
ucstudy@uci.edu