mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mpMRI + Diagnostic TURBT.
- Who it may be relevant to
- Registry conditions: Urothelial Bladder Cancer, Muscle-Invasive Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- Diagnostic test mpMRI + Diagnostic TURBT
mpMRI in addition to the TURBT surgical procedure
Primary outcome measures
- 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. [Time frame: Up to 1 year]
Secondary outcome measures (7)
- Progression free survival (PFS) with mpMRI compared to diagnostic TURBT [Time frame: 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 [Time frame: up to 5 years]
- Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI). [Time frame: up to 5 years]
- Incidence of adverse events with mpMRI versus diagnostic TURBT. [Time frame: up to 5 years]
- Patient Quality of Life with mpMRI versus diagnostic TURBT. [Time frame: up to 5 years]
- Incidence of repeat TURBT. [Time frame: up to 5 years]
- Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT [Time frame: up to 5 years]
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 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).
- 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 180 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Chao Family Comprehensive Cancer Center University of California, Irvine — Orange
Identifiers
NCT: NCT06335667 · 4565 · UCI 23-72