Fiducial Markers + Mp-MRI for Bladder Cancer
(FMBRT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to help doctors better target bladder cancer during radiation treatment. It uses tiny gold markers, known as fiducial markers, to pinpoint the tumor's original location, along with a special MRI scan called multiparametric MRI (mpMRI) that may detect cancer sooner and more accurately. The trial seeks participants with bladder cancer who plan to undergo chemoradiation and have not recently received certain treatments. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance cancer detection and treatment precision.
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 prior data suggests that fiducial marker placement and mp-MRI are safe for bladder cancer treatment?
Research has shown that fiducial markers used in bladder cancer treatment are generally safe and stable. These tiny markers help doctors aim radiation therapy more precisely at the tumor. Studies have found that using these markers can enhance treatment accuracy without causing significant side effects.
The mpMRI, or multiparametric MRI, is a common imaging technique that helps doctors see bladder cancer more clearly. This method is known to be safe and effective for detecting and assessing bladder cancer.
Overall, both fiducial markers and mpMRI have been well-tolerated in previous studies, with no major safety concerns reported.12345Why are researchers excited about this trial?
Researchers are excited about using fiducial markers with multiparametric MRI (mpMRI) for bladder cancer because this innovative approach could enhance the precision of chemo-radiotherapy. Unlike traditional treatment methods that rely on less detailed imaging, mpMRI offers detailed visualization of the bladder and surrounding tissues, allowing for more accurate targeting during radiation therapy. This improved targeting could potentially lead to better outcomes by minimizing damage to healthy tissues and enhancing the effectiveness of the treatment. Additionally, the use of fiducial markers helps in real-time tracking of tumor movement, further refining the precision of radiation delivery. Overall, this method represents a significant step forward in personalizing cancer treatment and improving patient care.
What evidence suggests that fiducial markers and mp-MRI are effective for bladder cancer?
Studies have shown that fiducial markers enhance the accuracy of radiation treatment for bladder cancer by clearly marking the tumor's location. This precision allows doctors to target the cancer more effectively, potentially increasing treatment efficacy and reducing side effects. Research indicates that these markers remain safe and stable in patients.
Research shows that multiparametric MRI (mpMRI) excels at detecting bladder cancer and assessing its spread. This advanced imaging aids in early cancer detection and effective treatment planning. In this trial, participants will receive both fiducial marker placement and mpMRI within a single treatment arm, aiming to improve bladder cancer detection and treatment.12467Who Is on the Research Team?
Maurice Garcia, MD
Principal Investigator
Cedars-Sinai Medical Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Fiducial Marker Placement
24-K gold fiducial markers are endoscopically implanted around the tumor resection area to mark the location of the tumor site
Radiotherapy Planning
Radiation planning CT scan and mpMRI are conducted to guide radiotherapy targeting
Chemo-radiation Treatment
Participants undergo chemo-radiation treatment with fiducial markers to minimize collateral radiation
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
What Are the Treatments Tested in This Trial?
Interventions
- Fiducial marker placement
- Multiparametric MRI (mpMRI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator