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

Korábbi kezelés

• Inability to stop antiplatelet and coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
• Unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atracurium, cisatracurium, etc.)
• Have taken an investigational agent within 30 days of visit 1
• Have implanted electronic devices or implants with metal parts in the vicinity of a lesion
• Have Q-T intervals greater than 550 ms unless treated with an Accysync Model 72 synchronization system controlling the NanoKnife system's output pulses
• 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

Más betegség

• 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
• Have implanted cardiac pacemakers or defibrillators
• Have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
• Have a recent history of myocardial infarction (within the past 2 months)

Laborértékek

• Creatinine > 2.0 mg/dL
• Any lab value with a grade 3 or 4 toxicity as defined by the CTCAE Version 5.0

Egyéb

• Tumor size not measurable
• Women who are pregnant or currently breast feeding
• Women of childbearing potential who are not utilizing an acceptable method of contraception
• Evidence of distant metastases of stage IV

• > = 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