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Drug Screening Using IMD in Bladder Cancer
Sponsor: Brigham and Women's Hospital
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.
Official title: Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Primary Bladder Tumors
Key Details
Gender
All
Age Range
18 Years - 120 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2024-06-14
Completion Date
2028-08-01
Last Updated
2026-05-18
Healthy Volunteers
Yes
Interventions
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.
Methotrexate
Methotrexate will be placed in reservoir 1 of the implantable microdevice.
Carboplatin
Carboplatin will be placed in reservoir 2 of the implantable microdevice.
Avelumab
Avelumab will be placed in reservoir 3 of the implantable microdevice.
Paclitaxel
Paclitaxel will be placed in reservoir 4 of the implantable microdevice.
Vinblastine
Vinblastine will be placed in reservoir 5 of the implantable microdevice.
Gemcitabine/Cisplatin I
Gemcitabine/Cisplatin will be placed in reservoir 6 of the implantable microdevice.
Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab
(Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab) will be placed in reservoir 7 of the implantable microdevice.
Gemcitabine/Cisplatin II
Gemcitabine/Cisplatin will be placed in reservoir 8 of the implantable microdevice.
Cisplatin
Cisplatin will be placed in reservoir 9 of the implantable microdevice.
Nivolumab
Nivolumab will be placed in reservoir 10 of the implantable microdevice.
Pembrolizumab
Pembrolizumab will be placed in reservoir 11 of the implantable microdevice.
Gemcitabine/Carboplatin
Gemcitabine/Carboplatin will be placed in reservoir 12 of the implantable microdevice.
Methotrexate/Vinblastine/Doxorubicin/Cisplatin
(Methotrexate/Vinblastine/Doxorubicin/Cisplatin) will be placed in reservoir 13 of the implantable microdevice.
Gemcitabine/Cisplatin/Nivolumab
(Gemcitabine/Cisplatin/Nivolumab) will be placed in reservoir 14 of the implantable microdevice.
Erdafitinib
Erdafitinib will be placed in reservoir 15 of the implantable microdevice.
Paclitaxel/Docetaxel/Ifosfamide
(Paclitaxel/Docetaxel/Ifosfamide) will be placed in reservoir 16 of the implantable microdevice.
Gemcitabine
Gemcitabine will be placed in reservoir 17 of the implantable microdevice.
Gemcitabine/Carboplatin/Nivolumab
(Gemcitabine/Carboplatin/Nivolumab) will be placed in reservoir 18 of the implantable microdevice.
Enfortumab
Enfortumab will be placed in reservoir 19 of the implantable microdevice.
Sacituzumab
Sacitzumab will be placed in reservoir 20 of the implantable microdevice.
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States