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

Summary

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.

Eligibility

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

Conditions2

Locations1 site

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