UnknownEarly Phase 1

Drug Screening Using IMD in Bladder Cancer

United States18 participantsStarted 2024-02-14

Plain-language 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 than a treatment dose) of different cancer drugs into the tumor. After approximately 72 hours, the devices and small regions of surrounding tissue will be removed and studied. There will be a follow-up visit within 42 days of device removal to assess for potential safety issues or side effects.

Who can participate

Age range18 Years – 120 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

What they're measuring

Safety of microdevice placement and removal based on assessment of adverse events

Timeframe: From the time of arrival to interventional radiology for microdevice placement up to 6 weeks.

Feasibility of microdevice placement

Timeframe: 48 Hours

Trial details

NCT IDNCT06204614

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-01

View on ClinicalTrials.gov More Muscle Invasive Bladder Urothelial Carcinoma trials