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Pilot Study of Implantable Microdevices for Pancreatic Cancer

This study is testing a new way to understand how pancreatic cancer responds to chemotherapy. Researchers will implant tiny devices, made by the Jonas Lab, directly into your tumor during surgery. These devices contain very small amounts of chemotherapy agents. After about four hours, the devices will be removed along with the tumor. The main goal is to see if placing and removing these devices is safe and doesn't cause more complications after surgery. You might be able to join if you are at least 18 years old, have suspected or confirmed pancreatic cancer, and are scheduled for a pancreatoduodenectomy (Whipple procedure). This study is currently unclear on its recruitment status and plans to enroll 10 participants.

Study design
This is an interventional pilot study, meaning it's a small-scale test of a new approach. It will involve 10 participants.
What's involved
If you participate, microdevices will be implanted into your tumor during surgery and removed with the tumor after four hours. You will be monitored for complications for one month after surgery.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be assessed for one year after the procedure.

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NCT07254091

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Northwell Health
~10 participants
Updated 2026-03-06 on ClinicalTrials.gov
What's tested:Device Arm with Therapeutic Agents

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 1 year

Conditions

Pancreatic Cancer

Explore related trials

Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
New York1

Who to contact

GI Trial Referral Team
[email protected]
(516) 734-8900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • 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 v5.0.1 year

    Safety will be defined by assessment of adverse events as defined in the CTCAE v5.0. Any device resulting in: * any listed Serious adverse events as defined in section 8.3.2, or * two or more grade 3-4 adverse events directly associated with the device or its placement as defined in section 8.3.3.2