Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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 :
Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria. [ Time Frame: Immediately post treatment to 2 years post treatment ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.