Carcinoma, Hepatocellular
Conditions
Keywords
HCC, Hepatocellular Carcinoma, Early Stage, Prospective, Multicenter, Irreversible Electroporation (IRE), Electroporation, Low Energy Direct Current, LEDC, Nonthermal ablation, NTIRE (nonthermal IRE), Ablation, Soft Tissue
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).
Interventions
DEVICEAblation with the NanoKnife Low Energy Direct Current (LEDC) System
90 pulses of 70 microseconds each in duration will be administered per electrode pair.
Sponsors
Angiodynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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. | 30 days (+/- 3 days) post treatment |
Secondary
| Measure | Time frame |
|---|---|
| Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria. | Immediately post treatment to 2 years post treatment |
Countries
France, Germany, Italy, Spain
Outcome results
None listed