Fiducial Markers + Mp-MRI for Bladder Cancer

(FMBRT Trial)

Recruiting at 3 trial locations

Overseen By Laura Sarmiento, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Intravesical chemo, Biologic therapy

Disqualifiers: Metastatic disease, Severe renal failure, others

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

Compensation: Varies

Number of Visits: 4

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the usefulness of implanting small 24-K gold fiducial markers around a bladder tumor site, so that a Radiation Oncologist can identify the original tumor location at the time of radiation treatment. Other goals of the study include assessing whether a new MRI imaging technology can help with detection of bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are receiving intravesical chemo- or biologic therapy, you must not have had it within 6 weeks of the first treatment.

What data supports the effectiveness of the treatment Fiducial Markers + Mp-MRI for Bladder Cancer?

Multiparametric MRI (mp-MRI) is effective in distinguishing between different stages of bladder cancer, which is crucial for selecting the best treatment approach. This imaging technique helps in accurately staging bladder cancer, aiding in better diagnosis and management. ^{1 2 3 4 5}

How is the treatment using fiducial markers and mp-MRI for bladder cancer different from other treatments?

This treatment is unique because it combines fiducial markers, which are small objects placed near a tumor to help guide radiation therapy, with multiparametric MRI (mp-MRI), a detailed imaging technique, to improve the accuracy of targeting bladder cancer during treatment. This approach aims to enhance the precision of radiation therapy by clearly defining the tumor's location and stage, potentially leading to better outcomes compared to traditional methods. ^{1 2 5 6 7}

Research Team

Maurice Garcia, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for adults with bladder cancer (urothelial carcinoma) that's not spread beyond the pelvis. They should be set to receive chemo and radiation but haven't had major bladder surgery or recent intravesical therapy. Good kidney function is needed, and they must use birth control if applicable.

Inclusion Criteria

My bladder cancer is at a stage where it's not spread far and I'm choosing to get chemoradiation.

Ability to understand and willingness to sign a written informed consent

I agree to use birth control during and for 3 months after the study.

Exclusion Criteria

I am scheduled for immune system treatment before surgery, but BCG vaccine is okay.

My cancer has spread to distant parts of my body like the lungs or liver.

I do not have any infections or uncontrolled conditions that would stop me from joining the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Fiducial Marker Placement

24-K gold fiducial markers are endoscopically implanted around the tumor resection area to mark the location of the tumor site

1 day

1 visit (in-person)

Radiotherapy Planning

Radiation planning CT scan and mpMRI are conducted to guide radiotherapy targeting

1-2 weeks

Chemo-radiation Treatment

Participants undergo chemo-radiation treatment with fiducial markers to minimize collateral radiation

2 weeks

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with mpMRI and/or surveillance cystoscopy at 3, 6, and 9 months post-treatment

9 months

3 visits (in-person)

Treatment Details

Interventions

• Fiducial marker placement
• Multiparametric MRI (mpMRI)

Trial Overview The study tests placing tiny gold markers near the tumor before radiation so doctors can target it better. It also checks if a new type of MRI scan can more accurately detect bladder cancer when scopes don't see it.

Participant Groups

Group I: Single Arm - Bladder Chemo-Radiotherapy Experimental Treatment 2 Interventions

Fiducial marker placement \& cystogram during resection surgery, followed by radiation planning CT scan, mpMRI, chemo-radiation treatment; mpMRI and/or surveillance cystoscopy at 3, 6, and 9 months post-treatment.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Multiparametric MRI (mp-MRI) is a valuable tool for accurately distinguishing between non-muscle-invasive and muscle-invasive bladder cancer, which is crucial for determining the best treatment options.

The Vesical Imaging Reporting and Data System provides standardized criteria for mp-MRI scanning and reporting, enhancing the consistency and reliability of bladder cancer assessments in both clinical and research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staging of bladder cancer with multiparametric MRI. Juri, H., Narumi, Y., Panebianco, V., et al.[2021]

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]

The Vesical Imaging-Reporting and Data System (VI-RADS) is a promising non-invasive tool for accurately staging bladder cancer, helping to differentiate between non-muscle-invasive (NMIBC) and muscle-invasive bladder cancer (MIBC).

This review analyzed 18 articles and included MRI images from patients diagnosed with bladder cancer between 2019 and 2021, highlighting the potential of VI-RADS in improving diagnostic pathways, although further prospective studies are needed to confirm its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VESICAL IMAGING-REPORTING AND DATA SYSTEM - A NEW APPROACH TO BLADDER CANCER STAGING. Jakimów, K., Sznajder, K.[2022]

Multi-parametric magnetic resonance imaging (mpMRI) demonstrated a high accuracy of 94% in differentiating muscle invasive bladder cancer (MIBC) from non-muscle invasive bladder cancer (NMIBC) in a study of 82 tumors, using histopathology as the reference standard.

The combination of diffusion-weighted imaging (DWI) and diffusion tensor imaging (DTI) provided significant differences in imaging parameters between cancerous and non-cancerous areas, suggesting that mpMRI could enhance the staging process and potentially lead to faster treatment for patients with MIBC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of morphological and functional multi-parametric MRI sequences in classifying non-muscle and muscle invasive bladder cancer. Panebianco, V., De Berardinis, E., Barchetti, G., et al.[2020]

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]

The study demonstrated that cystoscopy-guided placement of hydrogel markers in 32 patients with muscle-invasive bladder cancer is safe, with no procedure-related adverse events reported.

While 76.6% of the markers were sufficient for tumor delineation at the start, only 46.7% remained visible and adequate for routine verification by the end of treatment, indicating a need for improvement in marker performance during radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility and Utility of Cystoscopy-Guided Hydrogel Marker Placement in Patients With Muscle-Invasive Bladder Cancer. Wortel, K., Hovius, MC., van Andel, G., et al.[2020]

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. England pubmed.ncbi.nlm.nih.gov

Staging of bladder cancer with multiparametric MRI. [2021]

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

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

3. Poland pubmed.ncbi.nlm.nih.gov

VESICAL IMAGING-REPORTING AND DATA SYSTEM - A NEW APPROACH TO BLADDER CANCER STAGING. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

An evaluation of morphological and functional multi-parametric MRI sequences in classifying non-muscle and muscle invasive bladder cancer. [2020]

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

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

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

The Feasibility and Utility of Cystoscopy-Guided Hydrogel Marker Placement in Patients With Muscle-Invasive Bladder Cancer. [2020]

7. 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]