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Completed

NCT Number: NCT01369420

NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer

The purpose of this study is to evaluate the safety and feasibility of the NanoKnife Low Energy Direct Current (LEDC) System when used to treat unresectable pancreatic adenocarcinoma. Safety will be reviewed by means of analysis of adverse events, including serious adverse events, laboratory data, physician exam findings, and vital signs.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Policlinico "G.B. Rossi", University of Verona, Department of Surgery

Verona, 37134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male or female
  • >/= 18 years of age
  • meets criteria for locally advanced unresectable pancreatic adenocarcinoma, as radiographically proven pancreatic cancer as determined by a surgical oncologist via pancreatic CT or who were initially thought to be resectable; however at the time of surgery were upstaged to unresectability, via direct visualization
  • tumor size must be < 4 cm and must be measurable
  • must have an INR <1.5
  • must be unresponsive to chemotherapy as demonstrated with either CT or MR imaging and not have taken any chemotherapy agents within 14 days of treatment with the NanoKnife LEDC System
  • are willing and able to comply with the protocol requirements
  • are able to comprehend and willing to sign an Informed Consent Form (ICF)

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

NanoKnife Low Energy Direct Current (LEDC) System Ablation

Device

90 pulses of 70 microseconds each in duration will be administered per electrode pair.

Other names: ◦ Low Energy Direct Current (LEDC) System, ◦ HVP01 Electroporation System, ◦ NanoKnife LEDC System, ◦ NanoKnife IRE System, ◦ Non-Thermal Irreversible Eletroporation (NTIRE) System, ◦ Angiodynamics IRE System, ◦ Non-Thermal Ablation

Primary outcomes

  1. Safety

    Time frame: 90 days

    • reported adverse events and adverse effects/events (serious and non serious),
    • unanticipated adverse events and device complaints,
    • safety laboratory tests (hematology, chemistry, amylase, lipase),
    • vital signs,
    • physical findings (including symptoms, vital signs and weight changes)

Secondary outcomes

  1. Efficacy

    Time frame: 90 days

    Evaluation of short term efficacy based upon tumor evaluation and symptomatic response as defined by:

    • imaging will be used to evaluate changes in tumor size in addition to evaluating the completeness of ablation,
    • tumor evaluation by evaluating changes in CA-19-9 marker,
    • symptomatic changes of quality of life questionnaires,
    • physician assessment of the performance status of the subject,
    • pain assessment and subject analgesic consumption,
    • assessment of tumor for downstaging to resectability at the time of imaging

Sponsors and collaborators

Lead sponsor

Angiodynamics, Inc.

Industry

Registry information

Official study title

A Safety Evaluation of the NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer - A Pilot Study

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jun 9, 2011
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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