NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and feasibility of the NanoKnife Low Energy Direct Current (LEDC) System when used to treat unresectable pancreatic adenocarcinoma. Safety will be reviewed by means of analysis of adverse events, including serious adverse events, laboratory data, physician exam findings, and vital signs.

Official Title
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A Safety Evaluation of the NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer - A Pilot Study

Conditions
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Pancreatic Adenocarcinoma

Intervention / Treatment
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* Device: NanoKnife Low Energy Direct Current (LEDC) System Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female >/= 18 years of age meets criteria for locally advanced unresectable pancreatic adenocarcinoma, as radiographically proven pancreatic cancer as determined by a surgical oncologist via pancreatic CT or who were initially thought to be resectable; however at the time of surgery were upstaged to unresectability, via direct visualization tumor size must be < 4 cm and must be measurable must have an INR <1.5 must be unresponsive to chemotherapy as demonstrated with either CT or MR imaging and not have taken any chemotherapy agents within 14 days of treatment with the NanoKnife LEDC System are willing and able to comply with the protocol requirements are able to comprehend and willing to sign an Informed Consent Form (ICF) Exclusion Criteria: a baseline creatinine reported as > 2.0 mg/dL have any reported baseline lab values with a grade 3 or 4 toxicity as defined by the CTCAE Version 3.0 inability to stop antiplatelet and Coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System 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 immediate 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NanoKnife Low Energy Direct Current (LEDC) System Ablation|90 pulses of 70 microseconds each in duration will be administered per electrode pair.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | reported adverse events and adverse effects/events (serious and non serious), unanticipated adverse events and device complaints, safety laboratory tests (hematology, chemistry, amylase, lipase), vital signs, physical findings (including symptoms, vital signs and weight changes) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Evaluation of short term efficacy based upon tumor evaluation and symptomatic response as defined by: imaging will be used to evaluate changes in tumor size in addition to evaluating the completeness of ablation, tumor evaluation by evaluating changes in CA-19-9 marker, symptomatic changes of quality of life questionnaires, physician assessment of the performance status of the subject, pain assessment and subject analgesic consumption, assessment of tumor for downstaging to resectability at the time of imaging | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locoregional cancer therapy, pancreatic cancer, unresectable pancreatic cancer, pancreatic adenocarcinoma, locally advanced, unresectable pancreatic cancer, pancreatic cancer tumor ablation, NanoKnife tumor ablation for pancreatic cancer, NanoKnife LEDC system tumor ablation, Non thermal ablation, Irreversible electroporation for pancreatic cancer treatment, IRE for unresectable pancreatic cancer