Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiot
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 c
| Condition(s) | Bladder Cancer, Urinary Bladder Neoplasm, Urologic Neoplasms, Neoplasms, Urinary Bladder Diseases |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 d |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Cedars-Sinai Medical Center |
| Locations | Los Angeles, California, United States; Los Angeles, California, United States; Boston, Massachusetts, United States |
| Start date | 2020-07-01 |
| NCT ID | NCT04442724 |
| Official listing | https://clinicaltrials.gov/study/NCT04442724 |