Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy
Cedars-Sinai Medical Center
Summary
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.
Description
This study of fiducial markers in patients with localized muscle-invasive bladder cancer will enroll patients electing bladder preservation with tri-modal therapy. 24-K gold fiducial markers will be endoscopically implanted around the tumor resection area to mark the location of the tumor site, into the bladder wall submucosa space under direct visualization via a coaxial needle. The markers are visible on all imaging modalities, including all available on-table imaging (e.g., portal and cone-beam CT) used for radiotherapy. Reliable fiducial marker placement within the bladder may have the po…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Ability to underst…
Interventions
- ProcedureFiducial marker placement
placement of 24k gold fiducial markers surrounding the tumor site, at time of primary or re-staging bladder tumor resection
- Diagnostic TestMultiparametric MRI (mpMRI)
In this study, mp-MRI is defined as MRI that includes T1 \& T2 weighted sequences, diffusion weighted sequences, and Dynamic contrast enhanced (DCE) MRI sequences.
Locations (3)
- Cedars-Sinai Medical Center (CSMC)Los Angeles, California
- University of California Los AngelesLos Angeles, California
- Harvard School of Medicine/Massachusetts General Hospital (MGH)Boston, Massachusetts