NCT06204614

Drug Screening Using IMD in Bladder Cancer

Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Primary Bladder Tumors

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Muscle Invasive Bladder Urothelial Carcinoma

Interventions

Type	Name	Description
DEVICE	Implantable Micro-Device	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.
DRUG	Methotrexate	Methotrexate will be placed in reservoir 1 of the implantable microdevice.
DRUG	Carboplatin	Carboplatin will be placed in reservoir 2 of the implantable microdevice.
DRUG	Avelumab	Avelumab will be placed in reservoir 3 of the implantable microdevice.
DRUG	Paclitaxel	Paclitaxel will be placed in reservoir 4 of the implantable microdevice.
DRUG	Vinblastine	Vinblastine will be placed in reservoir 5 of the implantable microdevice.
DRUG	Gemcitabine/Cisplatin I	Gemcitabine/Cisplatin will be placed in reservoir 6 of the implantable microdevice.
DRUG	Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab	(Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab) will be placed in reservoir 7 of the implantable microdevice.
DRUG	Gemcitabine/Cisplatin II	Gemcitabine/Cisplatin will be placed in reservoir 8 of the implantable microdevice.
DRUG	Cisplatin	Cisplatin will be placed in reservoir 9 of the implantable microdevice.
DRUG	Nivolumab	Nivolumab will be placed in reservoir 10 of the implantable microdevice.
DRUG	Pembrolizumab	Pembrolizumab will be placed in reservoir 11 of the implantable microdevice.
DRUG	Gemcitabine/Carboplatin	Gemcitabine/Carboplatin will be placed in reservoir 12 of the implantable microdevice.
DRUG	Methotrexate/Vinblastine/Doxorubicin/Cisplatin	(Methotrexate/Vinblastine/Doxorubicin/Cisplatin) will be placed in reservoir 13 of the implantable microdevice.
DRUG	Gemcitabine/Cisplatin/Nivolumab	(Gemcitabine/Cisplatin/Nivolumab) will be placed in reservoir 14 of the implantable microdevice.
DRUG	Erdafitinib	Erdafitinib will be placed in reservoir 15 of the implantable microdevice.
DRUG	Paclitaxel/Docetaxel/Ifosfamide	(Paclitaxel/Docetaxel/Ifosfamide) will be placed in reservoir 16 of the implantable microdevice.
DRUG	Gemcitabine	Gemcitabine will be placed in reservoir 17 of the implantable microdevice.
DRUG	Gemcitabine/Carboplatin/Nivolumab	(Gemcitabine/Carboplatin/Nivolumab) will be placed in reservoir 18 of the implantable microdevice.
DRUG	Enfortumab	Enfortumab will be placed in reservoir 19 of the implantable microdevice.
DRUG	Sacituzumab	Sacitzumab will be placed in reservoir 20 of the implantable microdevice.

Timeline

• Start date: 2024-02-14
• Primary completion: 2024-07-01
• Completion: 2025-07-01
• First posted: 2024-01-12
• Last updated: 2024-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study