Muscle-Invasive Bladder Cancer, Urothelial Bladder Cancer
Conditions
Keywords
mpMRI, TURBT, VI-RADS score
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).
Interventions
DIAGNOSTIC_TESTmpMRI + Diagnostic TURBT
mpMRI in addition to the TURBT surgical procedure
Sponsors
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 0-3. * 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 180 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) with mpMRI compared to diagnostic TURBT | up to 5 years | Time from diagnostic test to cancer progression, recurrence, or death. |
| 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 | — |
| Incidence of adverse events with mpMRI versus diagnostic TURBT. | up to 5 years | — |
| Patient Quality of Life with mpMRI versus diagnostic TURBT. | up to 5 years | As assessed by quality of life questionnaires |
| Incidence of repeat TURBT. | up to 5 years | — |
| Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT | up to 5 years | in dollars |
Countries
United States
Contacts
CONTACTChao Family Comprehensive Cancer Center University of California, Irvine
CONTACTUniversity of California Irvine Medical
PRINCIPAL_INVESTIGATORNataliya Mar, MD
Chao Family Comprehensive Cancer Center
Outcome results
None listed