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

Launched by ENGLEWOOD HOSPITAL AND MEDICAL CENTER · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method called the NanoKnife Irreversible Electroporation System for patients with pancreatic cancer that cannot be surgically removed. The main goals of the study are to see how safe this treatment is and whether it can help reduce pain and improve the quality of life for patients. This treatment is being evaluated in people who have already undergone standard chemotherapy or radiation therapy but still have advanced cancer that cannot be operated on.

To participate in this trial, you must be at least 18 years old and have been diagnosed with locally advanced, unresectable pancreatic cancer. You should not have received any chemotherapy or radiation in the five weeks leading up to the treatment with the NanoKnife. There are some health criteria that may exclude you, such as high creatinine levels, certain allergies, or having specific medical devices implanted. If you join the study, you can expect to undergo the NanoKnife treatment, and researchers will monitor your safety, pain levels, and overall well-being afterward. The study is not yet recruiting participants, but it aims to gather important information that could help improve treatment options for pancreatic cancer patients in the future.

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Eligibility 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