A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer
NCT ID: NCT03899649
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
532 participants
OBSERVATIONAL
2019-05-08
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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IRE Cohort
Patients who received SOC and received IRE
SOC
Standard of Care treatment
NanoKnife System
Irreversible Electroporation
SOC Cohort
Patients who received SOC and did not receive IRE
SOC
Standard of Care treatment
Interventions
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SOC
Standard of Care treatment
NanoKnife System
Irreversible Electroporation
Eligibility Criteria
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Inclusion Criteria
2. Patient is 18 years of age and older
3. Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria
4. Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery
5. Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC
6. Patient has received 3 months of SOC per each participating institution's guidelines
7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
8. Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2.
9. Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System
10. Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC
Exclusion Criteria
2. 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
3. Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade
4. 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
18 Years
ALL
No
Sponsors
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Angiodynamics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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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.
Other Identifiers
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2019-ONC-02
Identifier Type: -
Identifier Source: org_study_id
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