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Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC)

This study has been completed.
Information provided by (Responsible Party):
Angiodynamics, Inc. Identifier:
First received: February 26, 2010
Last updated: November 7, 2016
Last verified: November 2016
The purpose of this study is to evaluate the safety and efficacy of the NanoKnife LEDC System for the treatment of early-stage hepatocellular carcinoma (HCC).

Condition Intervention
Carcinoma, Hepatocellular
Device: Ablation with the NanoKnife Low Energy Direct Current (LEDC) System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC)

Resource links provided by NLM:

Further study details as provided by Angiodynamics, Inc.:

Primary Outcome Measures:
  • Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging. [ Time Frame: 30 days (+/- 3 days) post treatment ]

Secondary Outcome Measures:
  • Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria. [ Time Frame: Immediately post treatment to 2 years post treatment ]

Enrollment: 26
Study Start Date: February 2010
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Ablation with the NanoKnife Low Energy Direct Current (LEDC) System
    90 pulses of 70 microseconds each in duration will be administered per electrode pair.
    Other Names:
    • System also known as:
    • * Low Energy Direct Current (LEDC) System
    • * HVP01 Electroporation System
    • * NanoKnife LEDC System
    • * NanoKnife IRE System

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HCC diagnosed by positive biopsy or non-invasive criteria,
  • not suitable for surgical resection or transplantation,
  • have at least one, but less than or equal to 3 tumors,
  • of the tumour(s) identified, each tumor must be ≤ 3 cm in diameter,
  • Child-Pugh class A,
  • Eastern Cooperative Oncology Group (ECOG) score of 0,
  • American Society of Anaesthesiologists (ASA) score ≤ 3,
  • a prothrombin time ratio > 50%,
  • platelet count > 50x109/L,
  • ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
  • are able to comprehend and willing to sign the written informed consent form (ICF),
  • have a life expectancy of at least 3 months.

Exclusion Criteria:

  • eligible for surgical treatment or transplantation for HCC,
  • presence of vascular invasion or extrahepatic metastases,
  • received previous treatment for HCC,
  • HCC developed on an already transplanted liver,
  • cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
  • any active implanted device (eg Pacemaker),
  • women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
  • have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
  • are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01078415

L'institut de cancerologie Gustave Roussy
Villejuif, Ile-de-France, France, 94805
Hopital Beaujon
Paris, France, 92110
Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin
Magdeburg, Germany, D-39120
University of Pisa School of Medicine
Pisa, Tuscany, Italy, 56124
Istituto Nazionale Tumori - Fondazione Pascale
Naples, Italy, 80131
Barcelona Clinic Liver Cancer Group, Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Angiodynamics, Inc.
Principal Investigator: Riccardo Lencioni, MD University of Pisa School of Medicine
Principal Investigator: Jordi Bruix, MD Barcelona Clinic Liver Cancer (BCLC) Group of the University of Barcelona
  More Information


Responsible Party: Angiodynamics, Inc. Identifier: NCT01078415     History of Changes
Other Study ID Numbers: ONC-205
Study First Received: February 26, 2010
Last Updated: November 7, 2016

Keywords provided by Angiodynamics, Inc.:
Hepatocellular Carcinoma
Early Stage
Irreversible Electroporation (IRE)
Low Energy Direct Current
Nonthermal ablation
NTIRE (nonthermal IRE)
Soft Tissue

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on April 21, 2017