RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the short and intermediate term safety of the NanoKnife Irreversible Electroporation System when used off-label to treat unresectable pancreatic cancer. In addition, the study will evaluate the efficacy of this device in treating pain associated with unresectable pancreatic cancer. Quality of life post-procedure will also be collected.

Official Title

Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation (IRE) System

Quick Facts

Study Start:2025-05-13

Study Completion:2035-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06937996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Cherif Boutros

CONTACT

(201) 608-2266

Cherif.Boutros@EHMCHealth.org

Jamie Ketas

CONTACT

201-894-3418

jamie.ketas@ehmchealth.org

Study Locations (Sites)

Englewood Hospital

Englewood, New Jersey, 07631

United States

Collaborators and Investigators

Sponsor: Englewood Hospital and Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-13

Study Completion Date2035-05-31

Study Record Updates

Study Start Date2025-05-13

Study Completion Date2035-05-31

Terms related to this study

Additional Relevant MeSH Terms

Pancreatic Cancer Non-resectable