A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer

Active, not recruiting

Brief Summary: This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). Eligible patients will be recruited over a 36-month period and participating institutions will enroll and provide data on consecutive patients that meet inclusion and exclusion criteria. Each patient will be followed up for the duration of the study or until death. The study will include two (2) cohorts: patients who received standard of care (SOC) and received irreversible electroporation (IRE) \[IRE cohort\], and patients who were treated with SOC and did not receive IRE \[SOC cohort\].

Recruitment & Eligibility

Inclusion Criteria

Provisions of signed and dated informed consent form
Patient is 18 years of age and older
Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria
Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery
Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC
Patient has received 3 months of SOC per each participating institution's guidelines
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2.
Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System
Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC

Exclusion Criteria

Participation in an interventional trial for pancreatic cancer during the study data collection period
Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy
Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade
Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE

Arm && Interventions

Group	Intervention	Description
IRE Cohort	SOC	Patients who received SOC and received IRE
IRE Cohort	NanoKnife System	Patients who received SOC and received IRE
SOC Cohort	SOC	Patients who received SOC and did not receive IRE

Primary Outcome Measures

Name	Time	Method
Overall Survival	Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.	To evaluate the effectiveness of the NanoKnife System when used for the ablation of Stage 3 PC in real world treatment settings, by testing the hypothesis that IRE with the NanoKnife System improves overall survival (OS)

Secondary Outcome Measures

Name	Time	Method

Locations (14): Presbyterian Hospital, Columbia
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New York, New York, United States
Moores Cancer Center, UC San Diego Health
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La Jolla, California, United States
Barnes-Jewish Hospital
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Saint Louis, Missouri, United States
Miami Cancer Institute
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Miami, Florida, United States
Wellstar Medical Group
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Marietta, Georgia, United States
Northwest Community Hospital
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Arlington Heights, Illinois, United States
University of Texas-Southwestern
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Dallas, Texas, United States
Mayo Clinic, Rochester
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Rochester, Minnesota, United States
University of Florida Health
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Gainesville, Florida, United States
Atrium Health
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Charlotte, North Carolina, United States
University of Iowa Healthcare
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Iowa City, Iowa, United States
NYU Langone
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New York, New York, United States
Norton Healthcare
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Louisville, Kentucky, United States
St. Luke's University Health Network
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Easton, Pennsylvania, United States