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

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ClinicalTrials.gov Identifier: NCT01078415
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Device: Ablation with the NanoKnife Low Energy Direct Current (LEDC) System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : February 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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


Primary Outcome Measures :
  1. 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 :
  1. Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria. [ Time Frame: Immediately post treatment to 2 years post treatment ]


Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078415


Locations
France
L'institut de cancerologie Gustave Roussy
Villejuif, Ile-de-France, France, 94805
Hopital Beaujon
Paris, France, 92110
Germany
Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin
Magdeburg, Germany, D-39120
Italy
University of Pisa School of Medicine
Pisa, Tuscany, Italy, 56124
Istituto Nazionale Tumori - Fondazione Pascale
Naples, Italy, 80131
Spain
Barcelona Clinic Liver Cancer Group, Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Angiodynamics, Inc.
Investigators
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

Publications:

Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT01078415     History of Changes
Other Study ID Numbers: ONC-205
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases