Recruiting

mpMRI vs. TURBT

Sponsor:

UCLA

Code:

NCT06335667

Conditions

Urothelial Bladder Cancer

Muscle-Invasive Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mpMRI + Diagnostic TURBT

Study Details

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).

Conditions

Urothelial Bladder Cancer

Muscle-Invasive Bladder Cancer

Study ID

NCT06335667

Start date

Mar 27, 2024

Status verified date

Feb, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 provider 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 180 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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: mpMRI + Diagnostic TURBT

Interventions

mpMRI + Diagnostic TURBT

mpMRI in addition to the TURBT surgical procedure

Primary outcome measure

  • Incidence of concordance between VI-RADS score of 4 or 5 (i.e. muscular propria is likely or very likely) on mpMRI and pathologic muscularis propria invasion (i.e. pT2 tumor stage) on diagnostic TURBT. [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

1-877-827-8839ucstudy@uci.edu

University of California Irvine Medical

marn@hs.uci.edu

Locations

Chao Family Comprehensive Cancer Center University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Nataliya Mar, MD

1-877-827-8839ucstudy@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

May 4, 2026

Last verified

Feb, 2026

Keywords

  • mpMRI
  • TURBT
  • VI-RADS score

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-05-04.