Bladder Fiducial Markers and Multiparametric-MRI (mp-MRI) to Optimize Bladder Chemo-radiotherapy

Open to people ages 18 years and up

• 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

• 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