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| ID | Type | Description | Link |
|---|---|---|---|
| UCI 23-72 | Other Identifier | UCI CFCCC |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mpMRI + Diagnostic TURBT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mpMRI + Diagnostic TURBT | Diagnostic Test | mpMRI in addition to the TURBT surgical procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) with mpMRI compared to diagnostic TURBT | Time from diagnostic test to cancer progression, recurrence, or death. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center University of California, Irvine | Contact | 1-877-827-8839 | ucstudy@uci.edu | |
| University of California Irvine Medical | Contact | marn@hs.uci.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nataliya Mar, MD | Chao Family Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center University of California, Irvine | Recruiting | Orange | California | 92868 | United States |
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| ID | Term |
|---|---|
| D000081364 | Multiparametric Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| 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. | As assessed by quality of life questionnaires | up to 5 years |
| Incidence of repeat TURBT. | up to 5 years |
| Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT | in dollars | up to 5 years |
| D003933 | Diagnosis |