3 Tesla MRI for Bladder Cancer

Overseen By Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Pregnancy, Renal insufficiency, Anxiety, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a new type of MRI scan, called 3 Tesla MRI, detects bladder cancer and determines its spread. Participants will undergo surgery to remove the bladder and lymph nodes (cystectomy and lymphadenectomy), with some also receiving chemotherapy. It is ideal for those diagnosed with bladder cancer who are scheduled for bladder surgery and have no MRI restrictions. As an unphased trial, this study offers participants the chance to contribute to advancing medical imaging techniques for bladder cancer detection.

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 trial coordinators or your doctor.

What prior data suggests that 3 Tesla MRI is safe for diagnosing bladder cancer?

A study of 55 patients found that a 3 Tesla MRI effectively identified muscle-invasive bladder cancer. This imaging technique allows doctors to see the cancer more clearly. No specific safety concerns have been reported for the MRI itself, as it is a common test used in many areas of medicine.

The trial also includes surgery, specifically cystectomy and lymphadenectomy, which are standard treatments for bladder cancer. These surgeries are generally safe, but like any surgery, they carry risks such as infection or bleeding.

For the group receiving chemotherapy, previous research shows that chemotherapy can cause side effects like nausea, tiredness, and hair loss, but these can vary depending on the person and the type of medication.

Overall, patients tolerate the MRI well, and the safety of the surgeries and chemotherapy aligns with standard medical knowledge. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for bladder cancer because they incorporate advanced imaging techniques to potentially improve surgical outcomes. Unlike the standard care options, which typically involve surgery and possibly chemotherapy, these treatments use a 3 Tesla MRI to provide ultra-high-resolution images both before and after surgery. This enables more precise tumor removal and better assessment of the cancer's spread, particularly when combined with lymphadenectomy and urinary diversion. Additionally, the inclusion of chemotherapy in one of the treatment arms might enhance the effectiveness of the surgical approach by targeting any remaining cancer cells. Overall, this trial could lead to more accurate surgeries and improved recovery rates for patients.

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

Studies have shown that a 3 Tesla MRI effectively detects bladder cancer, with a high accuracy rate of about 94.59% for identifying muscle-invasive bladder cancer. In this trial, participants will undergo a 3 Tesla MRI as part of their treatment. Research indicates that a 3 Tesla MRI accurately reveals the depth of cancer growth, aiding doctors in selecting the best treatment plan. Overall, a 3 Tesla MRI serves as a valuable tool for understanding bladder cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael V. Knopp, MD, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with confirmed bladder cancer who are scheduled for surgery to remove the bladder and lymph nodes. Participants must be able to consent and have no issues that would prevent them from undergoing an MRI, such as allergies to contrast agents or severe kidney problems.

Inclusion Criteria

Able and willing to give valid written informed consent

I am scheduled for surgery to remove my bladder and nearby lymph nodes.

I have been diagnosed with bladder cancer.

Exclusion Criteria

Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MR

Not pregnant, planning to become pregnant during the study, or nursing

No allergy to contrast agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline MRI

Participants undergo a 3 Tesla MRI scan at baseline to stage the primary tumor and regional lymph nodes

1 day

1 visit (in-person)

Neoadjuvant Chemotherapy

Participants may receive neoadjuvant chemotherapy, typically four 21-day courses of cisplatin-based therapy

12 weeks

Midpoint MRI

Participants undergo a 3 Tesla MRI scan after 2 courses of neoadjuvant chemotherapy to assess tumor response

1 day

1 visit (in-person)

Post-Chemotherapy MRI

Participants undergo a 3 Tesla MRI scan after completion of neoadjuvant chemotherapy

1 day

1 visit (in-person)

Surgery

Participants undergo radical cystectomy and lymph node dissection

1 day

1 visit (in-person)

Ex-vivo MRI and Pathology

Specimens from surgery are examined ex-vivo by ultra-high-field MRI and by the pathology department

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cystectomy and Lymphadenectomy
• Specimen Ultra-High field MRI

Trial Overview The study is evaluating how effective a high-powered 3 Tesla MRI is in detecting bladder cancer compared to standard approaches. Patients will undergo this advanced imaging before their planned surgeries.

How Is the Trial Designed?

Group I: MRI+surgery+chemotherapy Experimental Treatment 3 Interventions

3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI/chemotherapy

Group II: MRI+surgery Experimental Treatment 2 Interventions

3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

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]

Ferumoxtran-10-enhanced magnetic resonance imaging significantly improves the accuracy of nodal staging in bladder cancer patients, with postcontrast imaging showing a sensitivity increase from 76% to 96% for detecting pelvic metastases.

This imaging technique can identify metastases in normal-sized lymph nodes that would otherwise be missed, demonstrating its potential to enhance diagnostic capabilities in bladder cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary bladder cancer: preoperative nodal staging with ferumoxtran-10-enhanced MR imaging. Deserno, WM., Harisinghani, MG., Taupitz, M., et al.[2016]

A study involving 163 patients demonstrated that combining T2-weighted SPAIR imaging, dynamic contrast-enhanced (DCE) imaging, and diffusion-weighted (DW) imaging significantly improved the sensitivity (92.5%) and specificity (97.4%) for identifying bladder cancer stages compared to using T2 SPAIR imaging alone.

The apparent diffusion coefficient (ADC) values were significantly different between low-grade and high-grade bladder lesions, indicating that ADC can be a useful biomarker for assessing tumor aggressiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined T2 SPAIR, Dynamic Enhancement and DW Imaging Reliably Detect T Staging and Grading of Bladder Cancer With 3.0T MRI. Yuan, L., Li, D., Mu, D., et al.[2022]

Citations

1. ejrnm.springeropen.com ejrnm.springeropen.com/articles/10.1186/s43055-020-00343-7

Diagnostic performance of 3-tesla multiparametric MRI for ... The overall T2-WI diagnostic accuracy for the T stage was 72.3%, increased to be 87.1% for contrast-enhanced images, and 92.6% for DWI, reaching ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10888296/

Progress of Multiparameter Magnetic Resonance Imaging ... This review assesses the value of multiparameter MRI in the accurate evaluation of muscular invasion of bladder cancer, as well as the current status and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0302283825047694

Bladder Cancer Multiparametric Magnetic Resonance ... MRI (magnetic resonance imaging) scans can help urologists to better understand how deep bladder cancer has grown and the response to any ...

4. withpower.com withpower.com/trial/3-tesla-mri-for-bladder-cancer-b41e9

3 Tesla MRI for Bladder Cancer · Info for Participants In a study of 55 patients, 3.0T MRI demonstrated high sensitivity (94.59%) for detecting muscle invasive bladder cancer after transurethral resection, ...

5. pubs.rsna.org pubs.rsna.org/doi/10.1148/radiol.233459

Multiparametric MRI for Bladder Cancer: A Practical ... Multiparametric MRI of the bladder is highly accurate in the detection and local staging of bladder cancer. The Vesical Imaging Reporting and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03138837?cond=Effective%20diffusion%20coefficient&viewType=Table&rank=3

Role of 3 Tesla Diffusion Weighted Magnetic Resonance ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7446004/

Staging of bladder cancer with multiparametric MRI - PMC The two recent meta-analyses of MRI for evaluations of bladder cancer revealed that the pooled sensitivity and specificity were 90–92% and 78–88%, and that 3.0 ...