Bladder Fiducial Markers and Multiparametric MRI to Optimize Bladder Chemo-Radiotherapy

What is the Purpose of this Study?

This study focuses on individuals who have been diagnosed with muscle-invasive bladder cancer and are considering bladder-preserving treatment with a combination of maximal tumor resection, chemotherapy and radiation therapy. The purpose of the study is to examine the usefulness of implanting small (3 mm. x 1 mm.), 24-karat gold fiducial markers around the tumor site in the patient’s bladder so that the radiation oncologist can identify the original location of the patient’s tumor each day that they treat the bladder with radiation. The gold fiducial markers can generally be seen clearly during radiation treatment and are considered the best practice. These markers are used because the tumor site often does not show up well with conventional imaging during radiation treatment. Researchers will follow participants’ medical outcomes to determine whether implanting the markers improves how accurately the bladder/tumor site can be targeted (thereby avoiding radiation of organs or areas that should not be radiated). Other goals of the study include assessing whether an imaging technology called mpMRI (high-resolution multi-parametric MRI) can help detect bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope. Additionally, researchers will explore whether mpMRI can distinguish between tumor recurrence versus scar-tissue in the bladder that can look like a tumor among patients who have already had radiation treatment and are now undergoing post-treatment follow-up imaging (“cancer surveillance”).


Eligibility

  • * Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. Subjects with mixed histology are required to have a dominant traditional cell carcinoma (TCC) pattern.
  • * Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder
  • * Planned TURBT as part of the normal course treatment, to take place prior to the initiation of chemo irradiation
  • * Adequate renal function: Serum creatinine \< 2 mg/dL OR calculated creatinine clearance (CrCl) \> 30ml/min
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Where can I participate?

  • CS Cancer at Cedars-Sinai Medical Center : Laura Sarmiento
  • Massachusetts General Hospital (Study Affiliate)
  • UCLA (Study Affiliate)


More about this Clinical Trial

What is the full name of this clinical trial?

IIT2017-12-GARCIA-FMBRT: Bladder Fiducial Markers and Multi-parametric-MRI to Optimize Bladder Chemo-radiotherapy

Study Details
Disease Type/Condition

Bladder cancer, Urology

Principal Investigator

Garcia, Maurice

Co-Investigators

Jason Efstathiou

Age Group

Adult

Phase

N/A (Cancer Control)

IRB Number

Pro00050291

ClinicalTrials.gov ID

NCT04442724

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Laura Sarmiento

Phone
+1 310-423-4295
Email
laura.sarmiento@cshs.org
Study Detail
Disease Type/Condition

Bladder cancer, Urology

Principal Investigator

Garcia, Maurice

Age Group

Adult

Phase

N/A (Cancer Control)

IRB Number

IIT2017-12-GARCIA-FMBRT

ClinicalTrials.gov ID

NCT04442724

Key Eligibility
ClinicalTrials.gov

Contact
Name

Laura Sarmiento

Phone
+1 310-423-4295
Email
laura.sarmiento@cshs.org