A Study to Evaluate the NanoKnife SYstem for Stage 3 Pancreatic Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-005684
- Jacksonville, Florida: 20-005684
NCT ID: NCT03899649
Sponsor Protocol Number: 2019-ONC-02
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Rory Smoot, M.D. |
Closed for enrollment |
|
Jacksonville, Fla.
Mayo Clinic principal investigator John Stauffer, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available