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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
mpMRI in addition to the TURBT surgical procedure
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, United States
RECRUITINGIncidence 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.
Time frame: Up to 1 year
Progression free survival (PFS) with mpMRI compared to diagnostic TURBT
Time from diagnostic test to cancer progression, recurrence, or death.
Time frame: 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
Time frame: up to 5 years
Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI).
Time frame: up to 5 years
Incidence of adverse events with mpMRI versus diagnostic TURBT.
Time frame: up to 5 years
Patient Quality of Life with mpMRI versus diagnostic TURBT.
As assessed by quality of life questionnaires
Time frame: up to 5 years
Incidence of repeat TURBT.
Time frame: up to 5 years
Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT
in dollars
Time frame: up to 5 years
Chao Family Comprehensive Cancer Center University of California, Irvine
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