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

Not Applicable

Completed

• Conditions: Carcinoma, Hepatocellular

• Registration Number: NCT01078415
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Primary Completion: 2013-01
• Study Completion: 2013-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-07
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (6)

Barcelona Clinic Liver Cancer Group, Hospital Clinic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hopital Beaujon; 🇫🇷 Paris, France

Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin; 🇩🇪 Magdeburg, Germany

L'institut de cancerologie Gustave Roussy; 🇫🇷 Villejuif, Ile-de-France, France

University of Pisa School of Medicine; 🇮🇹 Pisa, Tuscany, Italy

Istituto Nazionale Tumori - Fondazione Pascale; 🇮🇹 Naples, Italy