mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer
Status
Conditions
Treatments
Details and patient eligibility
About
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).
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
Trial contacts and locations
Loading...
Central trial contact
Chao Family Comprehensive Cancer Center University of California, Irvine; University of California Irvine Medical
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal