Implantable microdevice placed during pancreatic cancer surgery to test tumor drug response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.