Clinical trial · Interventional
Drug Screening Using IMD in Bladder Cancer
Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Primary Bladder Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle Invasive Bladder Urothelial Carcinoma | Muscle Invasive Bladder Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (21)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avelumab | Drug | Avelumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Enfortumab | Drug | — | UNRESOLVED |
| Erdafitinib | Drug | Erdafitinib | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Gemcitabine/Carboplatin | Drug | — | UNRESOLVED |
| Gemcitabine/Carboplatin/Nivolumab | Drug | — | UNRESOLVED |
| Gemcitabine/Cisplatin I |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DRUG SCREENING USING IMD IN BLADDER CANCER
- description
- Study participants placed in arm 1 will be implanted with the microdevice.
- interventionNames
- 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
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patients must have the ability to understand and the willingness to sign a written informed consent document.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Participants must be 18 years of age or older.
8. Participants must be evaluated by a medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease.
9. Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures.
10. 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.
11. 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.
12. 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
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
Exclusion Criteria:
1. 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.
2. Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures (detailed below in section 5.1.2.1).References
Publications (0)
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