NCT07254091

Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Pancreatic Cancer

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Device Arm with Therapeutic Agents	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.

Timeline

• Start date: 2026-01-30
• Primary completion: 2027-01-30
• Completion: 2027-01-30
• First posted: 2025-11-28
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study