Comparing mpMRI and TURBT for diagnosing muscle-invasive bladder cancer
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
This study is testing whether a special type of MRI can accurately diagnose muscle-invasive bladder cancer compared to a common surgical procedure in patients who might have this type of cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06335667 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to validate the accuracy of the VI-RADS score obtained through multi-parametric magnetic resonance imaging (mpMRI) against the pathologic cancer stage determined by diagnostic transurethral bladder tumor resection (TURBT). It will also evaluate the clinical and quality of life outcomes associated with these two diagnostic methods in patients suspected of having muscle-invasive bladder cancer (MIBC). The study will enroll participants who meet specific eligibility criteria and will involve both imaging and surgical procedures to gather comprehensive data.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with suspected muscle-invasive bladder cancer as determined by initial cystoscopy.
Not a fit: Patients who have had prior TURBT or bladder cancer therapy within the last 120 days, or those unable to tolerate mpMRI or TURBT, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing muscle-invasive bladder cancer, leading to better treatment decisions and outcomes for patients.
How similar studies have performed: Other studies have shown promising results in using mpMRI for bladder cancer diagnosis, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Orange, California
- Chao Family Comprehensive Cancer Center University of California, Irvine — Orange, California, United States (Recruiting)
Study contacts
- Principal investigator: Nataliya Mar, MD — Chao Family Comprehensive Cancer Center
- Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
- Email: ucstudy@uci.edu
- Phone: 1-877-827-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.