A Study to Evaluate the NanoKnife SYstem for Stage 3 Pancreatic Cancer

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Provisions of signed and dated informed consent form.
  • Patient is 18 years of age and older.
  • Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria.
  • Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery.
  • Maximum axial and anterior to posterior tumor dimension of ≤ 3.5cm after SOC.
  • Patient has received 3 months of SOC per each participating institution’s guidelines.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1, 2, 3 or 4.
  • Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System.
  • Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC.

Exclusion Criteria:

  • Participation in an interventional trial for pancreatic cancer during the study data collection period.
  • 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.
  • Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sean Cleary, M.D.

Open for enrollment

Contact information:

Kimberly Nuhanovic CCRP

(507) 293-3905

Evatt.Kimberly@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

John Stauffer, M.D.

Open for enrollment

Contact information:

Mauricia Buchanan R.N.

Buchanan.Mauricia@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20509963

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