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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
mpMRI + Diagnostic TURBT
Diagnostic testmpMRI in addition to the TURBT surgical procedure
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: mpMRI + Diagnostic TURBTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 1 yearSecondary outcomes
1
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 years2
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 years3
Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI).
Time frame
up to 5 years4
Incidence of adverse events with mpMRI versus diagnostic TURBT.
Time frame
up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov