Actively Recruiting
Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation (IRE) System
Led by Englewood Hospital and Medical Center · Updated on 2025-06-17
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the short and intermediate term safety of the NanoKnife Irreversible Electroporation (IRE) System when used off-label to treat unresectable pancreatic cancer. The study also aims to assess how well this device manages pain related to this condition and collects information about patients' quality of life after the procedure. This observational study is sponsored by Englewood Hospital and Medical Center and focuses on patients with locally advanced pancreatic cancer that cannot be removed surgically. Participants will receive treatment using the NanoKnife System, a device approved by the FDA for soft tissue tumor ablation but not specifically cleared for pancreatic cancer treatment. The study observes patients after receiving this off-label therapy. Researchers will track safety and pain outcomes at multiple time points: 1, 2, 4, 7, 14, 21, and 30 days, and then at 3, 6, 9, 12, 15, 18, 21, and 24 months post-procedure. Throughout the study, participants will be monitored for adverse events and changes in pain using the Visual Analogue Score (VAS), as well as quality of life using EORTC QLQ-PAN26 and EORTC QLQ-C30 questionnaires. Safety assessments occur frequently early on and continue regularly for two years following treatment. This includes imaging evaluations before treatment to confirm eligibility and ongoing follow-up visits to evaluate health, symptoms, and overall well-being.
CONDITIONS
Brief Title
Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation System-
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with locally advanced unresectable pancreatic cancer after standard chemotherapy and/or radiotherapy
- Have not received chemotherapy or radiotherapy within 5 weeks prior to treatment with the NanoKnife IRE System
- INR (blood clotting) less than 1.5
- Willing and able to follow study procedures
- Able to understand and sign informed consent
You will not qualify if you...
- Creatinine level greater than 2.0 mg/dL
- Any lab value with grade 3 or 4 toxicity per CTCAE Version 5.0
- Unable to stop antiplatelet or coumadin therapy 7 days before and after NanoKnife treatment
- Tumor size not measurable
- Known contrast allergy that cannot be managed medically
- Known allergy to electrode metal (stainless steel 304L) that cannot be managed
- Unable to receive muscle blockade agents
- Pregnant or breastfeeding women
- Women of childbearing potential not using effective contraception
- Received investigational drugs within 30 days before visit 1
- Have implanted cardiac pacemakers, defibrillators, or electronic devices with metal near the lesion
- History of epilepsy or cardiac arrhythmia
- Recent heart attack within 2 months
- Q-T interval greater than 550 ms without synchronization system
- Evidence of distant metastases (stage IV)
- Received chemotherapy within 5 weeks before NanoKnife treatment
- Received stereotactic radiation or high-dose radiation above 54 Gray
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo the NanoKnife procedure for ablation of unresectable pancreatic cancer.
1 visit (in-person)
Duration - Up to 24 months
Participants are monitored for safety, pain, and quality of life after the NanoKnife procedure.
Multiple visits at 1, 2, 4, 7, 14, 21, and 30 days, then at 3, 6, 9, 12, 15, 18, 21, and 24 months post-procedure
Trial Site Locations
Total: 1 location
1
Englewood Hospital
Englewood, New Jersey, United States, 07631
Actively Recruiting
Research Team
C
Cherif Boutros
J
Jamie Ketas
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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