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

Last updated: June 12, 2025
Sponsor: Englewood Hospital and Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Treatment

NanoKnife

Clinical Study ID

NCT06937996
E-24-987
  • Ages > 18
  • All Genders

Study Summary

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.

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

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: NanoKnife
Phase:
Study Start date:
May 13, 2025
Estimated Completion Date:
May 31, 2035

Study Description

The NanoKnife, System has been commercially available since 2009, and is FDA-approved to treat soft tissue tumors. The NanoKnife System has received FDA clearance for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.

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.

Primary Objective:

• Safety and tolerability of the procedure by monitoring the number of participants with Adverse Events at the following time points: 1, 2, 4, 7, 14, 21 and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months post-IRE procedure.

Secondary Objective:

• Pain and Quality of Life outcomes of the patient using Pain Scores on the Visual Analogue Score (VAS) and Quality of Life Scores on the EORTC QLQ-PAN26 and EORTC QLQ-C30 at the following time points: 1, 2, 4, 7, 14, 21 and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months.

Connect with a study center

  • Englewood Hospital

    Englewood, New Jersey 07631
    United States

    Active - Recruiting

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