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

Trial Summary

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 data supports the effectiveness of this treatment for bladder cancer?

The research suggests that multiparametric MRI (mpMRI) can be a feasible alternative to traditional surgery (TURBT) for staging bladder cancer, as it provides a rapid, accurate, and noninvasive diagnosis. Early data from a clinical trial indicate that mpMRI, combined with a visual scoring system, can effectively identify bladder tumors that are unlikely to be invasive, potentially reducing the need for surgical intervention. ^{1 2 3 4 5}

Is mpMRI or TURBT safe for diagnosing bladder cancer?

Both mpMRI (a type of imaging scan) and TURBT (a surgical procedure to remove bladder tumors) are generally considered safe for diagnosing bladder cancer. However, the safety of TURBT in terms of cancer staging accuracy is still being evaluated, and mpMRI offers a noninvasive alternative that may reduce the need for surgery. ^{1 2 3 5 6}

How does the treatment mpMRI vs TURBT for bladder cancer differ from other treatments?

The treatment using mpMRI (multiparametric magnetic resonance imaging) offers a noninvasive and rapid way to stage bladder cancer, potentially replacing the need for surgical procedures like TURBT (transurethral resection of bladder tumor) in some cases. This approach uses imaging to assess the likelihood of muscle invasion, which can help in accurately identifying the stage of the cancer without the risks associated with surgery. ^{1 2 3 7 8}

What is the purpose of 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).

Research Team

Nataliya Mar, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 (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]

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]

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]

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 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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Bladder cancer local staging about muscle invasion: 3.0T MRI performance following transurethral resection]. [2020]

2. Switzerland 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Bladder cancer local staging: multiparametric MRI performance following transurethral resection. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Role of multiparametric magnetic resonance imaging in the diagnosis and staging of urinary bladder cancer. [2022]

5. Sweden 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). [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Value of multiparametric magnetic resonance imaging for local staging of invasive urinary bladder tumours. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

The accuracy of cystoscopy in predicting muscle invasion in newly diagnosed bladder cancer patients. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Perioperative outcomes of transurethral resection for t1 bladder tumors: quality evaluation based on patient, tumor and surgeon criteria. [2022]