mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
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).
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- mpMRI + Diagnostic TURBT
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov