A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer (DIRECT)

February 11, 2025 updated by: Angiodynamics, Inc.

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

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].

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

532

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • Moores Cancer Center, UC San Diego Health
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida Health
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute
    • Georgia
      • Marietta, Georgia, United States, 30060
        • WellStar Medical Group
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Community Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Healthcare
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic, Rochester
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
    • New York
      • New York, New York, United States, 10016
        • NYU Langone
      • New York, New York, United States, 10032
        • Presbyterian Hospital, Columbia
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Atrium Health
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • St. Luke's University Health Network
    • Texas
      • Dallas, Texas, United States, 75231
        • University of Texas-Southwestern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IRE Cohort
Patients who received SOC and received IRE
Drug: SOC
Standard of Care treatment
Device: NanoKnife System
Irreversible Electroporation
SOC Cohort
Patients who received SOC and did not receive IRE
Drug: SOC
Standard of Care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angiodynamics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2019

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-ONC-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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