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
N/A
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
Researchers are evaluating the use of small 24-karat gold fiducial markers implanted around bladder tumor sites in patients with localized muscle-invasive bladder cancer. The study aims to help radiation oncologists accurately identify the original tumor location during radiation treatment. Additionally, the trial examines whether a new multiparametric MRI (mp-MRI) technique can detect bladder cancer earlier and more precisely when it is not visible by scope. Participants will undergo placement of fiducial markers endoscopically around the tumor resection area into the bladder wall submucosa using a coaxial needle. These markers are visible on various imaging methods, including portal and cone-beam CT used during radiotherapy. The study involves bladder preservation with tri-modal therapy, including chemo-radiation guided by these markers and imaging. Follow-up includes mp-MRI and/or surveillance cystoscopy at 3, 6, and 9 months after treatment. During the study, participants will have assessments such as bladder volume measurements before and after marker placement, radiation dose evaluations, and imaging accuracy checks with mp-MRI at initial tumor resection and post-treatment. Researchers will monitor alignment improvements during radiotherapy and evaluate the sensitivity and specificity of mp-MRI for bladder cancer detection. Participant involvement includes imaging, cystoscopy, and chemo-radiation treatments over several months, with safety and treatment effectiveness carefully observed throughout the study period.
CONDITIONS
Brief 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 proven diagnosis of primary urothelial carcinoma of the bladder with a dominant traditional cell carcinoma pattern if mixed histology
- Clinical stage T2-T4a, Nx, M0, suitable for and choosing chemoradiation of the bladder
- Planned transurethral resection of bladder tumor (TURBT) before starting chemo-radiation
- Adequate kidney function with serum creatinine less than 2 mg/dL or creatinine clearance over 30 ml/min
- Ability to understand and willing to sign informed consent
- Women of childbearing potential and men agree to use adequate contraception during and for 90 days after study treatment
You will not qualify if you...
- Primary TCC of the ureter, urethra, or renal pelvis without bladder involvement
- Known distant metastatic disease such as lung or liver metastases
- Bladder abnormalities preventing safe fiducial marker placement (e.g., large diverticuli, active or recurrent urinary infection)
- Planned or prior definitive bladder irradiation
- Intravesical chemo- or biologic therapy within 6 weeks before treatment
- Planned neoadjuvant systemic immunotherapy (prior BCG vaccine is allowed)
- Active infection or uncontrolled medical condition precluding participation
- Pregnant or nursing women
- Previous malignancy other than TCC interfering with treatment
- Severe kidney failure preventing use of MRI contrast
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants undergo fiducial marker placement during bladder tumor resection, followed by chemo-radiation treatment guided by imaging including mpMRI.
1 surgery visit for marker placement and tumor resection; weekly visits during chemo-radiation treatment
Duration - Up to 9 months post-treatment
Participants receive mpMRI and/or surveillance cystoscopy to monitor treatment response and bladder health.
Visits at 3, 6, and 9 months post-treatment
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
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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