Implantable microdevice placed during pancreatic cancer surgery to test tumor drug response
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Pancreatic Cancer
This will test whether a tiny implantable device placed during pancreatic cancer surgery can show how an individual's tumor responds to chemotherapy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New Hyde Park, New York) |
| Trial ID | NCT07254091 on ClinicalTrials.gov |
What this trial studies
This is a prospective phase 1 safety study that places a small microdevice into pancreatic tumors during surgery and removes it en-bloc with the tumor after a 4-hour incubation. Patients will be monitored for one month after surgery to confirm that device placement and retrieval do not increase complication rates. Removed tissue around the device will be analyzed to measure drug diffusion and local chemotherapeutic effects. In an exploratory analysis, tumor material may be cultured into organoids to compare ex vivo drug responses.
Who should consider this trial
Good fit: Adults (≥18) with a suspicious or confirmed pancreatic lesion who are scheduled for pancreatoduodenectomy or pancreatectomy and deemed technically feasible for microdevice implantation by the operating surgical oncologist.
Not a fit: Patients who are not undergoing surgical resection (unresectable disease), are medically unfit for surgery, or who are pregnant are unlikely to benefit from this intraoperative device.
Why it matters
Potential benefit: If successful, this approach could help doctors choose more effective chemotherapy for each patient by showing which drugs reach and affect their tumor tissue.
How similar studies have performed: Microdevice approaches have shown promising preclinical and early clinical signals in other tumor types, but this is among the first evaluations specifically in pancreatic cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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
Where this trial is running
New Hyde Park, New York
- Zuckerberg Cancer Center — New Hyde Park, New York, United States (Recruiting)
Study contacts
- Study coordinator: GI Trial Referral Team
- Email: gitrialreferral@northwell.edu
- Phone: (516) 734-8900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.