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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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
- •Female patient who is known to be pregnant or breastfeeding.
Arms & Interventions
mpMRI + Diagnostic TURBT
Intervention: mpMRI + Diagnostic TURBT (Diagnostic Test)
Outcomes
Primary Outcomes
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
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 Outcomes
- Patient Quality of Life with mpMRI versus 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)
- Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT(up to 5 years)
- Progression free survival (PFS) with mpMRI compared to diagnostic TURBT(up to 5 years)
- Incidence of adverse events with mpMRI versus diagnostic TURBT.(up to 5 years)
- Incidence of repeat TURBT.(up to 5 years)
Investigators
Nataliya Mar
Associate Professor
University of California, Irvine