Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation System-

Recruiting now

Conditions studied: Pancreatic Cancer Non-resectable

In brief

The purpose of this study is to evaluate the short and intermediate term safety of the NanoKnife Irreversible Electroporation System when used off-label to treat unresectable pancreatic cancer. In addition, the study will evaluate the efficacy of this device in treating pain associated with unresectable pancreatic cancer. Quality of life post-procedure will also be collected.

Key facts

Study ID

NCT06937996

Run by

Englewood Hospital and Medical Center

People needed

25

Starts

2025-05-13

Expected to finish

2035-05-31

Last updated by the study team

2025-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > = 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

You may not qualify if…

• 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 is running

• Englewood Hospital — Englewood, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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