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NCT06204614

Drug Screening Using IMD in Bladder Cancer

Enrolling by Invitation
EARLY_PHASE1Ages 18+InterventionalTreatment
Brigham and Women's Hospital
~18 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Implantable Micro-DeviceMethotrexateCarboplatinAvelumabPaclitaxelVinblastine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of microdevice placement and removal based on assessment of adverse events
Measured over From the time of arrival to interventional radiology for microdevice placement up to 6 weeks.
+1 more outcome measured

Conditions

Muscle Invasive Bladder Urothelial Carcinoma

Explore related trials

Bladder Urothelial Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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 13. 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. 14. Patients must be agree to remain abstinent or use contraceptive measures for the duration of the study period

What this trial measures

  • Safety of microdevice placement and removal based on assessment of adverse eventsFrom the time of arrival to interventional radiology for microdevice placement up to 6 weeks.

    A device will be declared safe if and only if all implanted devices do not cause an adverse event as defined in section 5.4. The device will be declared safe if 2 or less unacceptable toxicities are observed. Safety will be monitored using a BOIN-based boundary estimated assuming a 10% event rate and a stopping probability of 0.70. The boundary will not take effect until the third patient is enrolled. The trial will be stopped for safety concerns if the investigators see at least 1 adverse event in the first nine patients, or 2 adverse events across all 18. The probability of seeing 2 or less unacceptable toxicity events is 71% if the true rate of toxicity is 10% and 94% if the true rate of toxicity is 5%. The safety estimate will be summarized as number, percentage and with a 95% binomial confidence interval

  • Feasibility of microdevice placement48 Hours

    A placement is defined as successful if the investigators can implant and extract at least one microdevice from a patient's tumor with readable tissue for pathology from at least three-quarters of the device reservoirs surrounded by at least 400um of surrounding tissue. The investigators will declare feasibility if the lower bound of the 95% binomial CI does not exceed 0.65, that is if the investigators have 2 or fewer failures. The number of patients with successful retrieval will be summarized as number, percentage and with a 95% CI. Based on prior studies, if device reservoirs are surrounded by at least 400um of tissue, this enables downstream multi-omic analysis.