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

Sponsor

Angiodynamics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01078415

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

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 :

Feb 1, 2010

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Outcome Measures

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. [30 days (+/- 3 days) post treatment]

Secondary Outcome Measures

Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria. [Immediately post treatment to 2 years post treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	L'institut de cancerologie Gustave Roussy	Villejuif	Ile-de-France	France	94805
2	Hopital Beaujon	Paris		France	92110
3	Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin	Magdeburg		Germany	D-39120
4	University of Pisa School of Medicine	Pisa	Tuscany	Italy	56124
5	Istituto Nazionale Tumori - Fondazione Pascale	Naples		Italy	80131
6	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