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

98 Participants Needed

Trial Summary

What is the purpose of this trial?

RATIONALE: New diagnostic procedures, such as 3 Tesla magnetic resonance imaging (MRI), may help find bladder cancer and learn the extent of disease. PURPOSE: This clinical trial is studying how well 3 Tesla MRI works in finding cancer in patients with bladder cancer.

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 data supports the effectiveness of the treatment Cystectomy and Lymphadenectomy, Specimen Ultra-High field MRI for bladder cancer?

Research shows that MRI, especially at higher strengths like 3.0T, is effective in accurately staging bladder cancer, which helps in planning treatments like cystectomy (surgical removal of the bladder) and lymphadenectomy (removal of lymph nodes). MRI has been found to be more accurate than CT scans in determining the extent of cancer spread, which is crucial for effective treatment. ^{1 2 3 4 5}

Is 3 Tesla MRI safe for humans?

The studies focus on the effectiveness of 3 Tesla MRI for diagnosing and staging bladder cancer, but they do not specifically address safety concerns. Generally, MRI is considered safe for humans as it does not use ionizing radiation, but specific safety data for 3 Tesla MRI in these studies is not provided. ^{1 3 6 7 8}

How does the treatment involving cystectomy and lymphadenectomy differ from other treatments for bladder cancer?

This treatment is unique because it combines surgical removal of the bladder (cystectomy) and nearby lymph nodes (lymphadenectomy) with advanced imaging using 3 Tesla MRI, which helps in accurately staging the cancer and planning the surgery. This approach may offer more precise detection of cancer spread compared to traditional methods. ^{1 2 4 9 10}

Research Team

Michael V. Knopp, MD, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

References

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

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

2. Ireland pubmed.ncbi.nlm.nih.gov

Diagnostic performance of MRI for prediction of muscle-invasiveness of bladder cancer: A systematic review and meta-analysis. [2022]

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

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

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

Staging of bladder carcinoma: MRI-CT-surgical correlation. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Relationship of MRI and clinical staging to outcome in invasive bladder cancer treated by radiotherapy. [2022]

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

The use of dynamic magnetic resonance imaging to evaluate orthotopic continent urinary diversion. [2015]

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

Urinary bladder cancer: preoperative nodal staging with ferumoxtran-10-enhanced MR imaging. [2016]

8. Switzerland 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. [2022]

9. Japan pubmed.ncbi.nlm.nih.gov

Preoperative T staging of urinary bladder cancer: efficacy of stalk detection and diagnostic performance of diffusion-weighted imaging at 3T. [2022]

10. France pubmed.ncbi.nlm.nih.gov

[Can MRI be used to distinguish between superficial and invasive transitional cell bladder cancer?]. [2019]