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

Muscle-Invasive Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335667
• Other study ID #: 4565
• Secondary ID: UCI 23-72
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2030

Study information

• Verified date: March 2024
• Source: University of California, Irvine
• Contact: Chao Family Comprehensive Cancer Center University of California
• Phone: 1-877-827-8839
• Email: ucstudy[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2030
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Muscle-Invasive Bladder Cancer
• Urinary Bladder Neoplasms
• Urothelial Bladder Cancer

Intervention

Diagnostic Test:
• mpMRI + Diagnostic TURBT
mpMRI in addition to the TURBT surgical procedure

Locations

Country	Name	City	State
United States	Chao Family Comprehensive Cancer Center University of California, Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression free survival (PFS) with mpMRI compared to diagnostic TURBT	Time from diagnostic test to cancer progression, recurrence, or death.	up to 5 years
Secondary	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
Secondary	Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI).		up to 5 years
Secondary	Incidence of adverse events with mpMRI versus diagnostic TURBT.		up to 5 years
Secondary	Patient Quality of Life with mpMRI versus diagnostic TURBT.	As assessed by quality of life questionnaires	up to 5 years
Secondary	Incidence of repeat TURBT.		up to 5 years
Secondary	Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT	in dollars	up to 5 years