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NanoKnife for Unresectable Pancreatic Cancer

This study is looking at the NanoKnife Irreversible Electroporation System to treat pancreatic cancer that cannot be removed by surgery (unresectable). The NanoKnife is a device that uses electrical pulses to destroy soft tissue tumors. While it's FDA-approved for general soft tissue ablation (removal), this study is using it to specifically treat unresectable pancreatic cancer. Researchers want to see how safe the NanoKnife is and if it helps reduce pain for patients with this type of cancer. They will also collect information on your quality of life after the procedure. This study plans to enroll 25 participants.

Study design
This is an observational study, meaning researchers will watch and collect information about participants who receive the NanoKnife treatment. It aims to enroll 25 participants.
What's involved
You would need to have locally advanced unresectable pancreatic cancer and not have received chemotherapy or radiation within 5 weeks of the NanoKnife treatment. Your blood clotting ability (INR) must also be less than 1.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and pain for up to 2 years after the procedure.

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NCT06937996

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

Recruiting
Not specifiedAges 18+Observational
Englewood Hospital and Medical Center
~25 participants
Updated 2025-06-17 on ClinicalTrials.gov
What's tested:NanoKnife

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Pain
Measured over 2 years
+1 more outcome measured

Conditions

Pancreatic Cancer Non-resectable

Explore related trials

Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
New Jersey1

Who to contact

Cherif Boutros
[email protected]
(201) 608-2266
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\> = 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

Exclusion

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

What this trial measures

  • Safety and Pain2 years

    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. The primary endpoint will be the number of Participants with an adverse event related to the IRE treatment and serious or non-serious, at least grade 3, at least possibly related to treatment This will be measured by a series of questionnaires on pain scores via Quality of Life scores via the EORTC QLQ-PAN26 and EORTC QLQ-C30. Pain will be measured on a scale from 0-10, with 0 being no pain and 10 being worst pain.

  • Safety and Pain2 years

    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. The primary endpoint will be the number of Participants with an adverse event related to the IRE treatment and serious or non-serious, at least grade 3, at least possibly related to treatment This will be measured by a series of questionnaires on pain scores via Visual Analogue Score (VAS).