A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer
DIRECT
Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma
1 other identifier
observational
532
1 country
14
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 \[SOC cohort\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedStudy Start
First participant enrolled
May 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedFebruary 12, 2025
February 1, 2025
5.9 years
March 29, 2019
February 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
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)
Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.
Study Arms (2)
IRE Cohort
Patients who received SOC and received IRE
SOC Cohort
Patients who received SOC and did not receive IRE
Interventions
Eligibility Criteria
Patients with cytologically or pathologically confirmed Stage 3 PC who are treated, in real-world treatment settings and as part of routine clinical practice, with the NanoKnife System (at least 266 patients) for the ablation of their tumor in addition to SOC (IRE cohort), or with SOC only (at least 266 patients) (SOC cohort). Patients will be enrolled after completing the initial 3-month treatment per SOC for Stage 3 PC.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Moores Cancer Center, UC San Diego Health
La Jolla, California, 92093, United States
University of Florida Health
Gainesville, Florida, 32608, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
Wellstar Medical Group
Marietta, Georgia, 30060, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
University of Iowa Healthcare
Iowa City, Iowa, 52242, United States
Norton Healthcare
Louisville, Kentucky, 40202, United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55905, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
NYU Langone
New York, New York, 10016, United States
Presbyterian Hospital, Columbia
New York, New York, 10032, United States
Atrium Health
Charlotte, North Carolina, 28204, United States
St. Luke's University Health Network
Easton, Pennsylvania, 18045, United States
University of Texas-Southwestern
Dallas, Texas, 75231, United States
Related Publications (1)
Narayanan G, Bilimoria MM, Hosein PJ, Su Z, Mortimer KM, Martin RCG 2nd. Multicenter randomized controlled trial and registry study to assess the safety and efficacy of the NanoKnife(R) system for the ablation of stage 3 pancreatic adenocarcinoma: overview of study protocols. BMC Cancer. 2021 Jul 7;21(1):785. doi: 10.1186/s12885-021-08474-4.
PMID: 34233640DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2019
First Posted
April 2, 2019
Study Start
May 8, 2019
Primary Completion
April 1, 2025
Study Completion
April 1, 2025
Last Updated
February 12, 2025
Record last verified: 2025-02