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

Recruitment & Eligibility

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.

Study & Design

Primary Outcome Measures

Name	Time	Method
Safety	90 days	* 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)

Secondary Outcome Measures

Name	Time	Method
Efficacy	90 days	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

Recruitment & Eligibility