Phase
Condition
Digestive System Neoplasms
Treatment
NanoKnife
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
> = 18 years of age
Must be found to have locally advanced unresectable disease following standardchemotherapy ± radiotherapy as demonstrated with either CT/MRI imaging and surgicalevaluation, and not have taken any chemotherapy/radiotherapy within 5 weeks oftreatment 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
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 dayspost 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) thatcannot 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 ofcontraception
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 alesion
Have a history of epilepsy or cardiac arrhythmia (atrial or ventricularfibrillation)
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 72synchronization 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 NanoKnifeIrreversible Electroporation (IRE) System
Received non-conventional fractionation schedules, such as stereotactic radiation (5fractions or less) or received higher than 54 Gray (Gy) delivered conventionally
Study Design
Study Description
Connect with a study center
Englewood Hospital
Englewood, New Jersey 07631
United StatesActive - Recruiting

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