Implantable Microdevice for Evaluation of Drug Response in Patients with Localized Bladder Cancer Undergoing Radical Cystectomy

Inclusion Criteria

• Patients must have the ability to understand and the willingness to sign a written informed consent document either in person or virtually via a 21 Code of Federal Regulations (CRF) Part 11 compliant platform
• Participants must have confirmed clinically localized bladder cancer with histology of urothelial cell carcinoma or variant histology and radiographic imaging consistent with stage T2-T3 N0 disease. Patients must be planned for cystectomy as part of their clinical care. The lesion planned for excision must be at least 1cm in size
• Participants must be 18 years of age or older
• Participants must be evaluated by a medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease
• Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures
• Absolute neutrophil count ≥ 1,000/mcL. If deemed necessary by the principal investigator (PI), within 180 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood draw)
• Platelets ≥ 50,000/mcL. If deemed necessary by the PI, within 180 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood draw)
• Prothrombin time (PT) (International normalized ratio [INR]) ≤ 1.5 and partial prothrombin time (PTT) < 1.5x control. If deemed necessary by the PI, within 180 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood draw)
• Participants must have undergone CT or MRI that assesses the extent of disease and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care
• The participant’s case must be reviewed by the treating physician to assess the following factors: * Patient is clinically stable to undergo microdevice implantation and surgical procedures * Patient has sufficient volume of disease to allow implantation of the microdevice * Patient has a lesion for which the microdevice is ** amenable to percutaneous placement, and ** amenable to removal at the time of surgery
• Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in National Institutes of Health (NIH) central data repositories
• Patients must agree to remain abstinent or use contraceptive measures for the duration of the study period

Exclusion Criteria

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery
• Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures