Muscle Invasive Bladder Urothelial CarcinomaEarly Phase 1NCT06204614
Drug Screening Using IMD in Bladder Cancer
A Early Phase 1 study testing Implantable Micro-Device, Methotrexate and Carboplatin in people with Muscle Invasive Bladder Urothelial Carcinoma, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Invasive Bladder Urothelial Carcinoma
- What is being tested?
- Implantable Micro-Device, Methotrexate and Carboplatin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2024to 1 Aug 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Primary Bladder Tumors
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.
Read the 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 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.
- Being tested
- Implantable Micro-Device, Methotrexate, Carboplatin, Avelumab, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Micro-DeviceDevice
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.
MethotrexateDrug
Methotrexate will be placed in reservoir 1 of the implantable microdevice.
CarboplatinDrug
Carboplatin will be placed in reservoir 2 of the implantable microdevice.
AvelumabDrug
Avelumab will be placed in reservoir 3 of the implantable microdevice.
PaclitaxelDrug
Paclitaxel will be placed in reservoir 4 of the implantable microdevice.
VinblastineDrug
Vinblastine will be placed in reservoir 5 of the implantable microdevice.
Gemcitabine/Cisplatin IDrug
Gemcitabine/Cisplatin will be placed in reservoir 6 of the implantable microdevice.
Methotrexate/Vinblastine/Doxorubicin/Cisplatin/AvelumabDrug
(Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab) will be placed in reservoir 7 of the implantable microdevice.
Gemcitabine/Cisplatin IIDrug
Gemcitabine/Cisplatin will be placed in reservoir 8 of the implantable microdevice.
CisplatinDrug
Cisplatin will be placed in reservoir 9 of the implantable microdevice.
NivolumabDrug
Nivolumab will be placed in reservoir 10 of the implantable microdevice.
PembrolizumabDrug
Pembrolizumab will be placed in reservoir 11 of the implantable microdevice.
Gemcitabine/CarboplatinDrug
Gemcitabine/Carboplatin will be placed in reservoir 12 of the implantable microdevice.
Methotrexate/Vinblastine/Doxorubicin/CisplatinDrug
(Methotrexate/Vinblastine/Doxorubicin/Cisplatin) will be placed in reservoir 13 of the implantable microdevice.
Gemcitabine/Cisplatin/NivolumabDrug
(Gemcitabine/Cisplatin/Nivolumab) will be placed in reservoir 14 of the implantable microdevice.
ErdafitinibDrug
Erdafitinib will be placed in reservoir 15 of the implantable microdevice.
Paclitaxel/Docetaxel/IfosfamideDrug
(Paclitaxel/Docetaxel/Ifosfamide) will be placed in reservoir 16 of the implantable microdevice.
GemcitabineDrug
Gemcitabine will be placed in reservoir 17 of the implantable microdevice.
Gemcitabine/Carboplatin/NivolumabDrug
(Gemcitabine/Carboplatin/Nivolumab) will be placed in reservoir 18 of the implantable microdevice.
EnfortumabDrug
Enfortumab will be placed in reservoir 19 of the implantable microdevice.
SacituzumabDrug
Sacitzumab will be placed in reservoir 20 of the implantable microdevice.
| Study group | Role | What they receive |
|---|---|---|
| DRUG SCREENING USING IMD IN BLADDER CANCER | Experimental | Study participants placed in arm 1 will be implanted with the microdevice. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 48 Hours
Secondary outcomes (2)
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.
Measured: 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.
Measured: 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start14 Jun 2024
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Jonas, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204614
- Sponsor's protocol ID
- 23-269
- Status last verified
- May 2026
- First submitted
- 11 Dec 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Primary Bladder Tumors
- ClinicalTrials.gov ID
- NCT06204614
- Acronym / sponsor ID
- 23-269
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DRUG SCREENING USING IMD IN BLADDER CANCER | Experimental | 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: SacituzumabStudy participants placed in arm 1 will be implanted with the microdevice. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Micro-DeviceThe 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. | Device | DRUG SCREENING USING IMD IN BLADDER CANCER |
| MethotrexateMethotrexate will be placed in reservoir 1 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| CarboplatinCarboplatin will be placed in reservoir 2 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| AvelumabAvelumab will be placed in reservoir 3 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| PaclitaxelPaclitaxel will be placed in reservoir 4 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| VinblastineVinblastine will be placed in reservoir 5 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| Gemcitabine/Cisplatin IGemcitabine/Cisplatin will be placed in reservoir 6 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab(Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab) will be placed in reservoir 7 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| Gemcitabine/Cisplatin IIGemcitabine/Cisplatin will be placed in reservoir 8 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| CisplatinCisplatin will be placed in reservoir 9 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| NivolumabNivolumab will be placed in reservoir 10 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| PembrolizumabPembrolizumab will be placed in reservoir 11 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| Gemcitabine/CarboplatinGemcitabine/Carboplatin will be placed in reservoir 12 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| Methotrexate/Vinblastine/Doxorubicin/Cisplatin(Methotrexate/Vinblastine/Doxorubicin/Cisplatin) will be placed in reservoir 13 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| Gemcitabine/Cisplatin/Nivolumab(Gemcitabine/Cisplatin/Nivolumab) will be placed in reservoir 14 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| ErdafitinibErdafitinib will be placed in reservoir 15 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| Paclitaxel/Docetaxel/Ifosfamide(Paclitaxel/Docetaxel/Ifosfamide) will be placed in reservoir 16 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| GemcitabineGemcitabine will be placed in reservoir 17 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| Gemcitabine/Carboplatin/Nivolumab(Gemcitabine/Carboplatin/Nivolumab) will be placed in reservoir 18 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| EnfortumabEnfortumab will be placed in reservoir 19 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
| SacituzumabSacitzumab will be placed in reservoir 20 of the implantable microdevice. | Drug | DRUG SCREENING USING IMD IN BLADDER CANCER |
Primary outcome
Safety of microdevice placement and removal based on assessment of adverse events
Time frame: From 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 placement
Time frame: 48 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.
2 secondary outcomes
Local intratumor response
Time frame: 48 Hours
Exploration of additional potential biomarkers of drug response
Time frame: 48 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Implantable Micro-Device, Methotrexate and Carboplatin in people with Muscle Invasive Bladder Urothelial Carcinoma, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of microdevice placement and removal based on assessment of adverse events (time frame: From the time of arrival to interventional radiology for microdevice placement up to 6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.