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

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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