Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation (IRE) System

NCT02041936 | Active Not Recruiting DMC

• 1 other identifier: HP-00052144
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the short and intermediate term outcomes of the NanoKnife Irreversible Electroporation System when used to treat unresectable pancreatic cancer. In addition, the study will evaluate the efficacy of this device in treating symptoms of unresectable pancreatic cancer. The NanoKnife, System has been commercially available since 2009, and is FDA-approved to treat soft tissue tumors. The NanoKnife System has received FDA clearance for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition. Irreversible electroporation (IRE) has the potential to dramatically widen the treatment options for patients with pancreatic cancer. It provides a minimally invasive procedure that could potentially avoid radical surgery for smaller lesions, and it could potentially offer palliation of symptoms such as pain, gastric outlet obstruction and jaundice in patients with locally advanced unresectable disease.

Conditions

Unresectable Pancreatic Cancer

Keywords

irreversible electroporation; Nanoknife; pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  1, 2, 4, 7, 14, 21 and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months post-IRE procedure

Secondary Outcomes (2)

• Pain Scores on the Visual Analogue Score (VAS)

  1, 4, 7, 14, 21, and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months post-IRE procedure

• Quality of Life on the EORTC QLQ-PAN26 and EORTC QLQ-C30

  1, 4, 7, 14, 21, and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months post-IRE procedure

Study Arms (1)

NanoKnife IRE System

EXPERIMENTAL

Device: NanoKnife IRE System

Interventions

NanoKnife IRE System DEVICE

NanoKnife IRE System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• years of age
• Must be found to have locally advanced unresectable disease following standard chemotherapy ± radiotherapy as demonstrated with either CT/MRI imaging and surgical evaluation, and not have taken any chemotherapy/radiotherapy within 5 weeks of treatment with the NanoKnife IRE System
• Must have an INR \< 1.5
• Are willing and able to comply with the protocol requirements
• Are able to comprehend and willing to sign an informed consent form

You may not qualify if:

• A baseline creatinine reported as \> 2.0 mg/dL
• Have any reported baseline lab values with a grade 3 or 4 toxicity as defined by the CTCAE Version 3.0
• Inability to stop antiplatelet and coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
• Tumor size not measurable
• Known history of contrast allergy that cannot be medically managed
• Known hypersensitivity to the metal in the electrodes (stainless steel 304L) that cannot be medically managed
• Unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atracurium, cisatracurium, etc.)
• Women who are pregnant or currently breast feeding
• Women of childbearing potential who are not utilizing an acceptable method of contraception
• Have taken an investigational agent within 30 days of visit 1
• Have implanted cardiac pacemakers or defibrillators
• Have implanted electronic devices or implants with metal parts in the immediate vicinity of a lesion
• Have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
• Have a recent history of myocardial infarction (within the past 2 months)
• Have Q-T intervals greater than 550 ms unless treated with an Accysync Model 72 synchronization system controlling the NanoKnife system's output pulses

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Cherif Boutros, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Surgical Oncology

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 22, 2014
• Study Start: April 1, 2014
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

US (1)