A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer

a study on Pancreatic Cancer Pancreatic Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Nadine Abi-Jaoudeh, MD

Description

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].

Official Title

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

Keywords

Stage III Pancreatic Cancer, Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Advanced Pancreatic Cancer, Carcinoma, Pancreatic Ductal, Locally Advanced Pancreatic Cancer, Cancer of Pancreas, Pancreatic Tumor, Pancreatic Carcinoma, Unresectable Pancreatic Cancer, LAPC, Pancreatic Neoplasms, SOC, NanoKnife System

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Locations

  • University of California, Irvine accepting new patients
    Orange California 92868 United States
  • Moores Cancer Center, UC San Diego Health accepting new patients
    La Jolla California 92093 United States

Lead Scientist at UC Irvine

  • Nadine Abi-Jaoudeh, MD
    Clinical Professor, Radiological Sciences, School of Medicine. Authored (or co-authored) 55 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Angiodynamics, Inc.
ID
NCT03899649
Study Type
Observational [Patient Registry]
Participants
Expecting 532 study participants
Last Updated
Contact us about this trial