mpMRI vs TURBT for Bladder Cancer

Overseen By University of California Irvine Medical

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Prior TURBT, Prior therapy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a special type of MRI (mpMRI) can better identify the stage of bladder cancer compared to a common surgery called TURBT (Transurethral Resection of Bladder Tumor). It focuses on individuals who might have muscle-invasive bladder cancer, where the cancer could be growing into the bladder muscle. Those informed they might have this type of bladder cancer and have not received certain treatments in the last 120 days may qualify for this trial. The study examines how these methods affect not only diagnosis but also patients' quality of life. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance diagnostic methods and patient outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these diagnostic methods are safe for patients with suspected muscle-invasive bladder cancer?

Research has shown that multi-parametric magnetic resonance imaging (mpMRI) is generally safe and well-tolerated for diagnosing bladder cancer. Studies have not identified any major safety concerns, confirming it as a safe procedure for patients.

In contrast, transurethral resection of bladder tumor (TURBT) carries some risks. Research indicates that about 8% of patients experience complications, with the most common being a urinary tract infection (UTI) within 30 days after the procedure. Despite these risks, TURBT remains a safe and standard method for diagnosing bladder cancer.

Overall, mpMRI maintains a strong safety record, while TURBT, despite some risks, is still widely used and accepted. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether mpMRI can be as effective or even better than the traditional TURBT procedure for diagnosing bladder cancer. Unlike TURBT, which is an invasive surgical method used to both diagnose and treat bladder cancer, mpMRI offers a non-invasive imaging technique that could potentially reduce the need for surgery. This means less discomfort and risk for patients, as well as quicker recovery times. If mpMRI proves to be as reliable as TURBT, it could transform the standard diagnostic process for bladder cancer, making it less invasive and more patient-friendly.

What evidence suggests that this trial's diagnostic methods could be effective for bladder cancer?

Research has shown that a special type of MRI scan, called multi-parametric MRI (mpMRI), effectively diagnoses bladder cancer. Studies have found that mpMRI helps doctors more accurately determine the stage of bladder cancer before surgery. This trial will compare mpMRI with the traditional method of removing bladder tumors through the urethra (TURBT). Using mpMRI can sometimes prevent the need for repeat TURBT procedures. Additionally, mpMRI can reduce the time to start treatments like surgery or combined chemotherapy and radiation by about 45 days. Overall, mpMRI offers a reliable and quicker way to understand and treat bladder cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Nataliya Mar, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with suspected muscle-invasive bladder cancer, as seen in initial cystoscopy. Participants must be able to undergo MRI and TURBT procedures, have an ECOG Performance Status of 0-3, and be willing to follow the study plan. Pregnant or breastfeeding women, those who've had prior bladder cancer therapy or TURBT within the last 120 days, or cannot tolerate MRI contrast are excluded.

Inclusion Criteria

I can care for myself but may not be able to do heavy physical work.

Willingness and ability to comply with the scheduled visits, imaging plan, follow up plan, and other specified study procedures in the opinion of the Investigator

Ability to understand and willingness to sign a written informed consent document (prior to the initiation of the study and any study procedures)

Exclusion Criteria

I cannot undergo an mpMRI or handle the contrast dye.

I had bladder tumor surgery less than 120 days ago.

I am completely unable to care for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Phase

Participants undergo multi-parametric MRI (mpMRI) and diagnostic transurethral resection of bladder tumor (TURBT) to assess VI-RADS score and pathologic cancer stage

4-6 weeks

Follow-up

Participants are monitored for progression-free survival, quality of life, and healthcare expenditure

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Diagnostic TURBT
• mpMRI

Trial Overview

The study tests how well a multi-parametric magnetic resonance imaging (mpMRI) can predict bladder cancer stage compared to the standard diagnostic method called transurethral resection of bladder tumor (TURBT). It's a single-arm pilot study that also looks at patient outcomes and quality of life following these diagnostic techniques.

How Is the Trial Designed?

Group I: mpMRI + Diagnostic TURBT Experimental Treatment 1 Intervention

Diagnostic TURBT is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Diagnostic TURBT for:

• Diagnosis and staging of bladder cancer

Approved in United States as Diagnostic TURBT for:

• Diagnosis and staging of bladder cancer

Approved in Canada as Diagnostic TURBT for:

• Diagnosis and staging of bladder cancer

Approved in Japan as Diagnostic TURBT for:

• Diagnosis and staging of bladder cancer

Approved in China as Diagnostic TURBT for:

• Diagnosis and staging of bladder cancer

Approved in Switzerland as Diagnostic TURBT for:

• Diagnosis and staging of bladder cancer

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

In a study of 55 patients, 3.0T MRI demonstrated high sensitivity (94.59%) for detecting muscle invasive bladder cancer after transurethral resection, indicating its effectiveness in identifying this condition.

Combining T2 weighted imaging (T2WI) and diffusion-weighted imaging (DWI) provided good accuracy (85.45%) for diagnosis, with T2WI excelling in locating tumors and DWI helping to distinguish between benign and malignant lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bladder cancer local staging about muscle invasion: 3.0T MRI performance following transurethral resection]. Zhao, SM., Yang, TJ., Xu, CM., et al.[2020]

Multiparametric MRI (mp-MRI) demonstrated the highest accuracy (95.4%) for diagnosing and staging urinary bladder cancer, significantly outperforming other imaging methods, and showed excellent agreement with histopathological results.

mp-MRI effectively differentiates between low- and high-grade bladder tumors, achieving a sensitivity of 93.3% and specificity of 98.3%, making it a reliable tool for preoperative assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of multiparametric magnetic resonance imaging in the diagnosis and staging of urinary bladder cancer. Shalaby, EA., Mohamed, AR., Elkammash, TH., et al.[2022]

In a study of 283 patients undergoing transurethral resection of bladder tumors (TURBT) for T1 urothelial cell carcinoma, muscle was found in 85.9% of first TURBT samples, indicating a generally effective initial procedure.

Surgeon's experience significantly reduced post-operative complications (13.4% overall), highlighting the importance of skill in performing TURBT, while factors like male gender and tumor multiplicity were linked to higher rates of residual disease during second-look resections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative outcomes of transurethral resection for t1 bladder tumors: quality evaluation based on patient, tumor and surgeon criteria. Bebane, S., Denize, J., Goujon, A., et al.[2022]

Multiparametric MRI (mpMRI) demonstrated high sensitivity (92% and 88%) and specificity (74% and 84%) for detecting muscle invasive bladder cancer in a study of 45 patients, indicating its effectiveness in local staging after tumor resection.

While mpMRI was specific for detecting peri-vesical invasion and regional nodal disease, it showed lower sensitivity (72% and 67% for peri-vesical invasion, and 45% for nodal disease), suggesting it may be more reliable for certain aspects of bladder cancer staging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bladder cancer local staging: multiparametric MRI performance following transurethral resection. van der Pol, CB., Shinagare, AB., Tirumani, SH., et al.[2022]

Multiparametric MRI (mpMRI) showed low to moderate accuracy in detecting muscle invasion in bladder cancer, with AUC values of 0.76 for one radiologist and 0.56 for another using the MRI visual T-category.

The subjective MRI visual T-category and the VI-RADS score did not significantly differ in performance, indicating that both methods have similar limitations in accurately identifying muscle invasion in bladder cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual MRI T-category versus VI-RADS evaluation from multiparametric MRI in the detection of muscle-invasion in patients with suspected bladder cancer: single centre registered clinical trial (MIB-trial). Nikulainen, I., Salminen, AP., Jambor, I., et al.[2022]

The BladderPath trial, involving 113 patients, suggests that using multiparametric MRI (mpMRI) for staging muscle-invasive bladder cancer (MIBC) is feasible and may reduce the need for transurethral resection of bladder tumor (TURBT), which is traditionally used for diagnosis.

The 5-point Likert scale effectively identifies patients with a low risk of MIBC, and initial results show that outpatient biopsies during flexible cystoscopy can accurately confirm bladder cancer, indicating a potential shift towards less invasive diagnostic methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing an Imaging-guided Pathway with the Standard Pathway for Staging Muscle-invasive Bladder Cancer: Preliminary Data from the BladderPath Study. Bryan, RT., Liu, W., Pirrie, SJ., et al.[2022]

In a study of 321 patients with suspected muscle-invasive bladder cancer (MIBC), urethrocystoscopy (UCS) demonstrated moderate accuracy in predicting muscle invasion, with a sensitivity of 71.8% and specificity of 89.9%.

Despite UCS showing some effectiveness, the results indicate that it should not replace transurethral resection of the bladder tumor (TURBT) for local staging, as it does not provide sufficient accuracy for definitive diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The accuracy of cystoscopy in predicting muscle invasion in newly diagnosed bladder cancer patients. van Straten, CGJI., Bruins, MH., Dijkstra, S., et al.[2023]

In a study of 37 patients with bladder cancer, multiparametric MRI (mpMRI) demonstrated a high sensitivity of 88% for detecting muscle-invasive bladder cancer (MIBC), indicating its potential effectiveness in improving initial tumor staging.

The specificity of mpMRI was lower at 58%, suggesting that while it is good at identifying MIBC, there may be some limitations in accurately ruling out non-muscle-invasive bladder cancer (NMIBC).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of multiparametric magnetic resonance imaging for local staging of invasive urinary bladder tumours. Huele, EH., Veenboer, PW., Wessels, FJ., et al.[2023]

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The 2-year RFS rates were 74.6% and 60% and the PFS rates were 91.2% and 87.5% in groups 1 and 2, respectively (23). These results emphasize the importance of ...

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ascopubs.org

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The overall complication rate of TURBT was 8.04% in 2022. Postprocedural urinary tract infection (UTI) - within 30 days after TURBT - was the most common ...

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sciencedirect.com

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