Ablation of unresectable pancreatic cancer with the NanoKnife irreversible electroporation system
Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation (IRE) System
This study will try using the NanoKnife irreversible electroporation device to see if it is safe and can reduce pain and improve quality of life for adults with locally advanced unresectable pancreatic cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Englewood Hospital and Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Englewood, New Jersey) |
| Trial ID | NCT06937996 on ClinicalTrials.gov |
What this trial studies
This is a single-center observational study using the NanoKnife (irreversible electroporation) off-label to treat locally advanced, unresectable pancreatic cancer. The project tracks short- and intermediate-term safety by recording adverse events at multiple early time points and out to 24 months after the procedure. Secondary outcomes include patient-reported pain (VAS) and quality of life (EORTC QLQ-PAN26 and QLQ-C30) measured at the same time points. All treatments are performed at Englewood Hospital and Medical Center with imaging and clinical follow-up per protocol.
Who should consider this trial
Good fit: Adults (≥18) with locally advanced, unresectable pancreatic cancer after standard chemotherapy ± radiotherapy who meet labs/coagulation criteria and can stop anticoagulants as required are ideal candidates.
Not a fit: Patients with significant kidney dysfunction (creatinine >2.0 mg/dL), uncontrolled coagulopathy or grade 3–4 lab toxicities, unmanageable metal or contrast allergies, non-measurable tumors, or inability to undergo required muscle blockade or stop anticoagulation are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the procedure could offer a local tumor-directed option that reduces pain and improves quality of life for patients who are not candidates for surgery.
How similar studies have performed: Prior small observational series of irreversible electroporation in pancreatic cancer have shown feasibility and some symptom relief but no large randomized trials proving clear survival benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \> = 18 years of age * Must be found to have locally advanced unresectable disease following standard chemotherapy ± radiotherapy as demonstrated with either CT/MRI imaging and surgical evaluation, and not have taken any chemotherapy/radiotherapy within 5 weeks of treatment with the NanoKnife IRE System * Must have an INR \< 1.5 * Are willing and able to comply with the protocol requirements * Are able to comprehend and willing to sign an informed consent form Exclusion Criteria: * Creatinine \> 2.0 mg/dL * Any lab value with a grade 3 or 4 toxicity as defined by the CTCAE Version 5.0 * Inability to stop antiplatelet and coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System * Tumor size not measurable * Known history of contrast allergy that cannot be medically managed * Known hypersensitivity to the metal in the electrodes (stainless steel 304L) that cannot be medically managed * Unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atracurium, cisatracurium, etc.) * Women who are pregnant or currently breast feeding * Women of childbearing potential who are not utilizing an acceptable method of contraception * Have taken an investigational agent within 30 days of visit 1 * Have implanted cardiac pacemakers or defibrillators * Have implanted electronic devices or implants with metal parts in the vicinity of a lesion * Have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation) * Have a recent history of myocardial infarction (within the past 2 months) * Have Q-T intervals greater than 550 ms unless treated with an Accysync Model 72 synchronization system controlling the NanoKnife system's output pulses * Evidence of distant metastases of stage IV * Have taken any chemotherapeutic agent within 5 weeks of treatment with the NanoKnife Irreversible Electroporation (IRE) System * Received non-conventional fractionation schedules, such as stereotactic radiation (5 fractions or less) or received higher than 54 Gray (Gy) delivered conventionally
Where this trial is running
Englewood, New Jersey
- Englewood Hospital — Englewood, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Cherif Boutros
- Email: Cherif.Boutros@EHMCHealth.org
- Phone: (201) 608-2266
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.