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

Launched by CEDARS-SINAI MEDICAL CENTER · Jun 19, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to improve treatment for bladder cancer. Researchers want to see if placing tiny gold markers around the tumor can help doctors accurately find the tumor during radiation therapy. They are also testing a special type of MRI scan that might help detect bladder cancer earlier and more precisely, even when it's not visible through other methods.

To be eligible for this study, participants should have a confirmed diagnosis of bladder cancer and be planning to undergo a specific surgical procedure called TURBT before starting treatment. They should also be between the ages of 65 and 74 and in good overall health. If you join the trial, you can expect to have these markers placed and receive advanced imaging to help in your treatment. It's important to know that certain health conditions or previous treatments may prevent some individuals from participating, but the research team will guide you through the eligibility process.

Gender

ALL

Eligibility criteria

• 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