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Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 understand and willingness to sign a written informed consent * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during study participation, and for 90 days after study treatment discontinuation * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Exclusion Criteria: * Subjects with primary TCC of the ureter, urethra, or renal pelvis, without TCC of the bladder, are not allowed * Known distant metastatic disease (e.g. pulmonary or hepatic metastases) * Subjects with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of complete resection of all malignant disease are allowed * Patients with bladder abnormalities that preclude safe placement of fiducial markers (i.e. abundant large diverticuli or cellules, active or recurrent urinary infection) * Planned (or prior history of) definitive bladder irradiation * Intravesical chemo- or biologic therapy within 6 weeks of first treatment * Any planned neoadjuvant systemic immunotherapy. Note that prior bacille Calmette-Guerin vaccine (BCG) is not an exclusion * Clinically significant active infection or uncontrolled medical condition that would preclude participation in study * Pregnant or nursing women are excluded * Previous malignancy other than TCC that, in the opinion of the treating investigator, is likely to interfere with protocol treatment * Individuals with severe renal failure and cannot receive MRI contrast
About the study
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.
What is being tested
- Fiducial marker placement (procedure)
- Multiparametric MRI (mpMRI) (diagnostic test)
Sponsor: Cedars-Sinai Medical Center · Participants: 60 · Started: Jul 1, 2020
Contact the study team
- Laura Sarmiento, CCRP · Phone: 310-423-4295
Official record on ClinicalTrials.gov — NCT04442724
Locations in the U.S.
| California | Cedars-Sinai Medical Center (CSMC), Los Angeles University of California Los Angeles, Los Angeles |
| Massachusetts | Harvard School of Medicine/Massachusetts General Hospital (MGH), Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.