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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03899649
Other study ID # 2019-ONC-02
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 8, 2019
Est. completion date December 2024

Study information

Verified date January 2024
Source Angiodynamics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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 information / eligibility

Status Active, not recruiting
Enrollment 532
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Provisions of signed and dated informed consent form 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: 1. Participation in an interventional trial for pancreatic cancer during the study data collection period 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SOC
Standard of Care treatment
Device:
NanoKnife System
Irreversible Electroporation

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Angiodynamics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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