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

Not Applicable

Recruiting

• Conditions: Muscle-Invasive Bladder Cancer; Urothelial Bladder Cancer
• Interventions: Diagnostic Test: mpMRI + Diagnostic TURBT

• Registration Number: NCT06335667
• Lead 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study Start: 2024-03-27
• Study First Posted: 2024-03-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mpMRI + Diagnostic TURBT	mpMRI + Diagnostic TURBT	-

Primary Outcome Measures

Name	Time	Method
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.	Up to 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Patient Quality of Life with mpMRI versus diagnostic TURBT.	up to 5 years	As assessed by quality of life questionnaires
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
Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT	up to 5 years	in dollars
Progression free survival (PFS) with mpMRI compared to diagnostic TURBT	up to 5 years	Time from diagnostic test to cancer progression, recurrence, or death.
Incidence of adverse events with mpMRI versus diagnostic TURBT.	up to 5 years
Incidence of repeat TURBT.	up to 5 years

Trial Locations

Locations (1)

Chao Family Comprehensive Cancer Center University of California, Irvine; 🇺🇸 Orange, California, United States