An Early Phase 1 interventional study of Implantable Micro-Device and Methotrexate in Muscle Invasive Bladder Urothelial Carcinoma, sponsored by Brigham and Women's Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Brigham and Women's Hospital · Early Phase 1, Interventional, and Treatment
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.
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 percutaneously using imaging guidance. The purpose of the microdevice is to measure local intratumor response to antitumor medications in patients with primary bladder cancer. The microdevice contains multiple, separate reservoirs that are each loaded with a specific drug or drug combination.
Candidate patients will first be evaluated based on a CT or MRI, obtained as part of clinical care, and a physician who will determine whether the target lesion is amenable for microdevice implantation. Microdevice implantation will occur via cystoscopy using a flexible grasper (similar to that used for ureteral stent removal). Several independent microdevices will be placed per patient and target lesion. After implantation, the reservoirs release microdoses of each drug allowing the drug to interact with the tumor tissue in its native microenvironment. After device removal and before pathologic analysis, a repeat plain film X-ray of the bladder will be obtained to evaluate for microdevice migration. The microdevice(s) will be removed along with the target tumor as part of standard-of-care surgical excision. The tumor tissue surrounding the device will undergo pathologic and molecular analysis to assess local drug efficacy for each reservoir. These analyses will explore the impact of drug treatment on local cellular processes (e.g., apoptosis, pathway signaling).
The investigators will also investigate preliminary correlations between drug response as assessed by the microdevice and clinical outcomes and response to therapy. Collectively, these studies will establish the feasibility of clinical application of a drug-sensitivity microdevice in bladder cancer and the capacity of such a device to predict systemic response to cancer therapeutics.
Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
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The participant's case must be reviewed by the treating physician to assess the following factors:
Exclusion Criteria:
Study participants placed in arm 1 will be implanted with the microdevice.
Device: Implantable Micro-Device · Drug: Methotrexate · Drug: Carboplatin · Drug: Avelumab · Drug: Paclitaxel · Drug: Vinblastine · Drug: Gemcitabine/Cisplatin I · Drug: Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab · Drug: Gemcitabine/Cisplatin II · Drug: Cisplatin · Drug: Nivolumab · Drug: Pembrolizumab · Drug: Gemcitabine/Carboplatin · Drug: Methotrexate/Vinblastine/Doxorubicin/Cisplatin · Drug: Gemcitabine/Cisplatin/Nivolumab · Drug: Erdafitinib · Drug: Paclitaxel/Docetaxel/Ifosfamide · Drug: Gemcitabine · Drug: Gemcitabine/Carboplatin/Nivolumab · Drug: Enfortumab · Drug: Sacituzumab
The implantable microdevice will release microdoses of specific drugs or drug combinations as a possible tool to evaluate the effectiveness of several cancer drugs against bladder cancer.
Methotrexate will be placed in reservoir 1 of the implantable microdevice.
Carboplatin will be placed in reservoir 2 of the implantable microdevice.
Avelumab will be placed in reservoir 3 of the implantable microdevice.
Paclitaxel will be placed in reservoir 4 of the implantable microdevice.
Vinblastine will be placed in reservoir 5 of the implantable microdevice.
Gemcitabine/Cisplatin will be placed in reservoir 6 of the implantable microdevice.
(Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab) will be placed in reservoir 7 of the implantable microdevice.
Gemcitabine/Cisplatin will be placed in reservoir 8 of the implantable microdevice.
Cisplatin will be placed in reservoir 9 of the implantable microdevice.
Nivolumab will be placed in reservoir 10 of the implantable microdevice.
Pembrolizumab will be placed in reservoir 11 of the implantable microdevice.
Gemcitabine/Carboplatin will be placed in reservoir 12 of the implantable microdevice.
(Methotrexate/Vinblastine/Doxorubicin/Cisplatin) will be placed in reservoir 13 of the implantable microdevice.
(Gemcitabine/Cisplatin/Nivolumab) will be placed in reservoir 14 of the implantable microdevice.
Erdafitinib will be placed in reservoir 15 of the implantable microdevice.
(Paclitaxel/Docetaxel/Ifosfamide) will be placed in reservoir 16 of the implantable microdevice.
Gemcitabine will be placed in reservoir 17 of the implantable microdevice.
(Gemcitabine/Carboplatin/Nivolumab) will be placed in reservoir 18 of the implantable microdevice.
Enfortumab will be placed in reservoir 19 of the implantable microdevice.
Sacitzumab will be placed in reservoir 20 of the implantable microdevice.
Safety of microdevice placement and removal based on assessment of adverse events
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
Time frame: From the time of arrival to interventional radiology for microdevice placement up to 6 weeks.
Feasibility of microdevice placement
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.
Time frame: 48 Hours
Local intratumor response
To measure the local intratumor response to clinically relevant drugs in bladder cancer using quantitative histopathologic assessment of tumor tissue. The investigators will analyze tumor sections for each drug treatment zone using a immunohistochemical stain for apoptosis (cleaved caspase 3) and report the result for each condition as a percentage of positively stained cells (vs. total number of cells) within a radius of 500 microns from the drug reservoir. A board-certified pathologist will review staining quality of the histopathological staining.
Time frame: 48 Hours
Exploration of additional potential biomarkers of drug response
To explore additional potential biomarkers of drug response. We will perform immunohistochemical staining for markers of proliferation (ki67) and cell death (Cleaved Parp) in the local tumor tissue adjacent to the microdevice. Results will be calculated as a percentage of positively stained cells in the 500 micron radius adjacent to each reservoir on the microdevice, and will be reported as a percentage of positively stained versus total cells in the region of interest. Descriptive statistics will be used to summarize the results for each biomarker across multiple devices and drugs.
Time frame: 48 Hours
Plan to share: Undecided
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