Clinical trial NCT06335667: mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer
Official title: Outcomes With Multi Parametric MRI (mpMRI) Compared to Diagnostic Transurethral Resection of Bladder Tumor (TURBT) in Patients With Suspected Muscle-Invasive Bladder Cancer - a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urothelial Bladder Cancer
Muscle-Invasive Bladder Cancer
Keywords: mpMRI
TURBT
VI-RADS score
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Up to 1 year
Secondary outcomes:
measure: Progression free survival (PFS) with mpMRI compared to diagnostic TURBT
timeFrame: up to 5 years
measure: Time from intervention that determines invasiveness of bladder tumors (i.e. diagnostic TURBT versus mpMRI) to initiation of cancer-directed therapy
timeFrame: up to 5 years
measure: Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI).
timeFrame: up to 5 years
measure: Incidence of adverse events with mpMRI versus diagnostic TURBT.
timeFrame: up to 5 years
measure: Patient Quality of Life with mpMRI versus diagnostic TURBT.
timeFrame: up to 5 years
measure: Incidence of repeat TURBT.
timeFrame: up to 5 years
measure: Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center University of California, Irvine
state: California
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: Nataliya Mar, MD
role: PRINCIPAL_INVESTIGATOR
References: