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

NCT06335667 | Recruiting FDA Device

• 2 other identifiers: 4565UCI 23-72
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

mpMRI; TURBT; VI-RADS score

Outcome Measures

Primary Outcomes (1)

• 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.

  VI-RADS is a five-point scoring system developed to standardize imaging and reporting of bladder tumor invasiveness on mpMRI. It predicts the degree of possible muscular propria invasion ("muscle-invasiveness") of bladder tumors. Once diagnostic TURBT is performed, the VI-RADS score from mpMRI will be compared to the pathologic tumor (T) stage from a diagnostic TURBT to assess for concordance.

  Up to 1 year

Secondary Outcomes (7)

• Progression free survival (PFS) with mpMRI compared to diagnostic TURBT

  up to 5 years

• Time from intervention that determines invasiveness of bladder tumors (i.e. diagnostic TURBT versus mpMRI) to initiation of cancer-directed therapy

  up to 5 years

• Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI).

  up to 5 years

• Incidence of adverse events with mpMRI versus diagnostic TURBT.

  up to 5 years

• Patient Quality of Life with mpMRI versus diagnostic TURBT.

  up to 5 years

Study Arms (1)

mpMRI + Diagnostic TURBT

EXPERIMENTAL

Diagnostic Test: mpMRI + Diagnostic TURBT

Interventions

mpMRI + Diagnostic TURBT DIAGNOSTIC_TEST

mpMRI in addition to the TURBT surgical procedure

mpMRI + Diagnostic TURBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Interventions

Multiparametric Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nataliya Mar, MD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

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

University of California Irvine Medical

CONTACT

marn@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: March 27, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-02

Locations

US (1)