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

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.

Eligibility

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

Conditions6

Locations3 sites

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