Who is eligible for clinical trial NCT07254091?

Participants must meet protocol criteria for Pancreatic Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07254091 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-04

Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Pancreatic Cancer (NCT07254091)

🟢 Recruiting Early Phase1 💊 Investigational Drug / Biologic Sponsor: Northwell Health

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (5 items).

Location: Zuckerberg Cancer Center — New Hyde Park, New York

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Patients must be at least or greater than18 years old
All sexes, genders, races, and ethnic groups are eligible for this trial
Patients with a suspicious or histologically confirmed pancreatic lesion for which surgery is indicated for either diagnostic or therapeutic purposes, as determined by the treating surgeon
Patients must be a candidate for pancreatoduodenectomy or pancreatectomy
Patients must be evaluated by the operating Surgical Oncologist to determine the feasibility of microdevice implantation based on clinical history, extent, and anatomical location of the tumor seen on baseline imaging
The effects of the microdevice on the developing human fetus is unknown. For this reason and because the therapeutic agents used in this trial are known to be teratogenic, women of childbearing age must agree to have a negative serum pregnancy test within 48 hours prior to operation.
Patient must be willing and able to understand and sign informed consent for both the surgical resection as well as the proposed research study obtained prior to any procedures
Males and females of childbearing potential must agree to use effective contraception starting prior to the first day of treatment and continuing for 30 days after the implantation of the microdevice. Additionally, due to the unknown but potential risks of nursing infants secondary to the treatment of the mother with the chemotherapeutic agents used in this study, breastfeeding should be discontinued for a total of 14 days after the insertion of the microdevice.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Patients with a tumor in a location not amenable to placement of the device prior to the removal of the tumor specimen as determined by the Surgical Oncologist
Any patient that is pregnant at the time of enrollment or operative intervention is excluded due to the known teratogenicity of the medications involved.
Patients with a history of prior or concurrent second primary malignancy whose natural history or treatment has the potential to interfere with the safety or primary endpoint efficacy assessment of the pancreas cancer
Patients with metastatic or locally advanced disease on baseline imaging

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Zuckerberg Cancer Center — New Hyde Park, New York

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗