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Predicting drug response offers an opportunity to improve cancer treatment delivery. Recently, microdevices were invented to ascertain in vivo drug response but have not yet been evaluated for pancreatic cancer. This study is a prospective phase 1 safety study of intraoperative placement and retrieval of a microdevice in patients with pancreatic cancer. The devices will be implanted intra-operatively and removed en-bloc with the tumor after a 4- hour incubation period. Patients will be monitored to ensure that the placement and retrieval of these devices does not increase complication rates within one month of surgery. To assess feasibility, the tissue surrounding the microdevices is then analyzed to determine the diffusion of drugs from the device(s) to surrounding tissue, and whether the chemotherapeutic effect of diffusing chemotherapy drug has an impact on the surrounding tissue. In an exploratory analysis, material from the patient's tumors will be grown into organoids and drug response correlation from organoids will be compared to the response observed from the microdevices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | This is a single institution pilot study to be performed on a limited number of patients (10) to establish safety and feasibility. There will be only one cohort of patients included and one intervention, the insertion of the microdevice prior to resection of the specimen with the device implanted. All patients will receive this intervention, thereby eliminating any potential bias on confounders. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device Arm with Therapeutic Agents | Combination Product | Devices manufactured by the Jonas Lab containing microdoses (1/100,000th standard dosage) of chemotherapy agents will be implanted and remain in situ for 4 hours, after which resection of the tumor and corresponding microdevice(s) are removed. The chemotherapeutic agents include Doxorubicin, Gemcitabine , Paclitaxel, 5 Fluorouracil , Oxaliplatin, and Irinotecan. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of micro dosing devices placement and retrieval based on adverse events by assessment of adverse events as defined in the CTCAE v5.0. | Safety will be defined by assessment of adverse events as defined in the CTCAE v5.0. Any device resulting in:
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 1. To determine the feasibility of microdevice analysis after the intra-operative placement and retrieval of the devices with sufficient associated tissue for histopathologic assessment of drug sensitivity. | To determine the feasibility of microdevice placement and retrieval based on the ability to retrieve the device with sufficient tissue, of sufficient quality , for downstream histopathology analysis and interpretation of at least 50% of the device reservoirs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GI Trial Referral Team | Contact | (516) 734-8900 | gitrialreferral@northwell.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg Cancer Center | Recruiting | New Hyde Park | New York | 11040 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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|
| 1 year |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |