A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer

Running, not enrolling

Conditions studied: Stage III Pancreatic Cancer

In brief

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 \[SOC cohort\].

Key facts

Study ID

NCT03899649

Run by

Angiodynamics, Inc.

People needed

532

Starts

2019-05-08

Expected to finish

2025-04-01

Last updated by the study team

2025-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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