Actively Recruiting
Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy
Led by Cedars-Sinai Medical Center · Updated on 2025-08-14
60
Participants Needed
3
Research Sites
312 weeks
Total Duration
On this page
Sponsors
C
Cedars-Sinai Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed diagnosis of primary urothelial carcinoma of the bladder with dominant traditional cell carcinoma pattern if mixed histology
- Clinical stage T2-T4a, Nx, M0 and electing to receive chemoradiation of the bladder
- Planned transurethral resection of bladder tumor (TURBT) before starting chemoradiation
- Adequate kidney function defined as serum creatinine less than 2 mg/dL or creatinine clearance greater than 30 ml/min
- Ability to understand and willing to sign informed consent
- Women of child-bearing potential and men must agree to use contraception before, during, and for 90 days after study treatment
- Immediate reporting to physician if pregnancy is suspected during study participation
You will not qualify if you...
- Primary transitional cell carcinoma (TCC) of ureter, urethra, or renal pelvis without bladder involvement
- Known distant metastatic disease such as pulmonary or hepatic metastases
- Bladder abnormalities preventing safe fiducial marker placement, including large diverticuli or active/recurrent urinary infection
- Planned or prior definitive bladder irradiation
- Intravesical chemotherapy or biologic therapy within 6 weeks before first treatment
- Planned neoadjuvant systemic immunotherapy (prior BCG vaccine is allowed)
- Clinically significant active infection or uncontrolled medical condition preventing participation
- Pregnant or nursing women
- Previous malignancy other than TCC that may interfere with treatment
- Severe kidney failure preventing MRI contrast use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Cedars-Sinai Medical Center (CSMC)
Los Angeles, California, United States, 90048
Actively Recruiting
2
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
Harvard School of Medicine/Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
L
Laura Sarmiento, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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