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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.
ClinicalTrials.gov Identifier:
NCT01078415
First received: February 26, 2010
Last updated: September 26, 2011
Last verified: September 2011
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: February 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2011 (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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108.

Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT01078415     History of Changes
Other Study ID Numbers: ONC-205
Study First Received: February 26, 2010
Last Updated: September 26, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Germany: Ethics Commission
Italy: Ethics Committee
Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on June 18, 2013