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