A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer

Stage III Pancreatic Cancer Clinical Trial

— DIRECT  

Official title:

Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03899649
• Other study ID #: 2019-ONC-02
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Stage III Pancreatic Cancer

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.