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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT06335667
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • mpMRI + Diagnostic TURBT — DIAGNOSTIC_TEST
    mpMRI in addition to the TURBT surgical procedure

Study Details

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).

Key Dates

Start date
Mar 27, 2024
Status verified
Feb 2026
Primary completion
Dec 1, 2026
Completion
Apr 30, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: mpMRI + Diagnostic TURBT

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

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center University of California, IrvineOrangeCalifornia92868
Nataliya Mar, MD
1-877-827-8839

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