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

• ClinicalTrials.gov Identifier: NCT03899649
• Recruitment Status: Recruiting
• First Posted: April 2, 2019
• Last Update Posted: December 20, 2022
• Sponsor: Angiodynamics, Inc.
• Information provided by (Responsible Party): Angiodynamics, Inc.

Tracking Information

• First Submitted Date: March 29, 2019
• First Posted Date: April 2, 2019
• Last Update Posted Date: December 20, 2022
• Actual Study Start Date: May 8, 2019
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 1, 2019)

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)

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer
• Official Title: Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma
• 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].
• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 24 Months
• Biospecimen: Not Provided
• 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.
• Condition: Stage III Pancreatic Cancer

Intervention

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

Study Groups/Cohorts

• IRE Cohort
  Patients who received SOC and received IRE
  Interventions:

  • Drug: SOC
  • Device: NanoKnife System
• SOC Cohort
  Patients who received SOC and did not receive IRE
  Intervention: Drug: SOC

• Publications *: 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 1, 2019): 532
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Elizabeth Manning; (339) 237-2765; liz.manning@angiodynamics.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03899649
• Other Study ID Numbers: 2019-ONC-02
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Angiodynamics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Angiodynamics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Angiodynamics, Inc.
• Verification Date: December 2022