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

November 7, 2016 updated by: Angiodynamics, Inc.

A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
30 days (+/- 3 days) post treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONC-205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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