Status:
NOT_YET_RECRUITING
Drug Screening Using IMD in Bladder Cancer
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Muscle Invasive Bladder Urothelial Carcinoma
Eligibility:
All Genders
18-120 years
Phase:
EARLY_PHASE1
Brief Summary
This research study involves implanting up to 4 microdevices, each small enough to fit inside the tip of a needle, into a tumor. These devices will release microdoses (many thousands of times less tha...
Detailed Description
This is a phase I pilot study of microdevice implantation and retrieval in patients with primary bladder cancer. The microdevice is 5x1mm and can be deployed using a biopsy needle placed percutaneousl...
Eligibility Criteria
Inclusion
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
- 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. Patients must have the ability to understand and the willingness to sign a written informed consent document.
- 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. Patients must have the ability to understand and the willingness to sign a written informed consent document.
- 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.
- Participants will undergo laboratory testing within 30 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood draw). Patients must have absolute neutrophil count ≥1,000/mcL, platelets ≥50,000/mcL, PT (INR) 1.5 and PTT\<1.5x control.
- 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 a) amenable to percutaneous placement, and b) 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 NIH central data repositories.
- Patients must be agree to remain abstinent or use contraceptive measures for the duration of the study period
Exclusion
- 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 (detailed below in section 5.1.2.1).
Key Trial Info
Start Date :
February 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06204614
Start Date
February 14 2024
End Date
July 1 2025
Last Update
January 12 2024
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115