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Fiducial Markers + Mp-MRI for Bladder Cancer (FMBRT Trial)
N/A
Recruiting
Led By Maurice Garcia, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder
Adequate renal function: Serum creatinine < 2 mg/dL OR calculated creatinine clearance (CrCl) > 30ml/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up radiotherapy treatment period (days 14-28)
Awards & highlights
FMBRT Trial Summary
This trial is testing whether gold markers can help doctors better target radiation therapy for bladder cancer, and whether a new MRI technology can improve cancer detection.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort from marker placement, typical MRI-related issues like claustrophobia or allergic reactions to contrast dye used during the scan.
FMBRT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder cancer is at a stage where it's not spread far and I'm choosing to get chemoradiation.
Select...
My kidney function is good, with creatinine below 2 mg/dL or clearance above 30ml/min.
FMBRT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ radiotherapy treatment period (days 14-28)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~radiotherapy treatment period (days 14-28)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bladder volume differential
Secondary outcome measures
Difference in alignment when markers are incorporated into the planning
Net dose radiation to collateral organs differential
Positive Predictive Value of Multiparametric-MRI (mp-MRI)
FMBRT Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm - Bladder Chemo-RadiotherapyExperimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fiducial marker placement
2003
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
502 Previous Clinical Trials
165,633 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,304 Total Patients Enrolled
Maurice Garcia, MDPrincipal InvestigatorCedars-Sinai Medical Center
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