Status:
RECRUITING
Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation System-
Lead Sponsor:
Englewood Hospital and Medical Center
Conditions:
Pancreatic Cancer Non-resectable
Eligibility:
All Genders
18+ years
Brief 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 add...
Detailed 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 tis...
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
Key Trial Info
Start Date :
May 13 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2035
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06937996
Start Date
May 13 2025
End Date
May 31 2035
Last Update
June 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Englewood Hospital
Englewood, New Jersey, United States, 07631