Ablation of unresectable pancreatic cancer with the NanoKnife irreversible electroporation system

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Englewood Hospital
  Englewood, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Cherif Boutros
• Email: Cherif.Boutros@EHMCHealth.org
• Phone: (201) 608-2266

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.