Irreversible Electroporation(IRE) For Unresectable Head and Neck Neoplasms

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Head and Neck Neoplasms.

Detailed Description
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By enrolling patients with unresectable Head and Neck Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Head and Neck Neoplasms.

Official Title
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Irreversible Electroporation(IRE) For Unresectable Head and Neck Neoplasms: Phase I and Phase II Clinical Trial

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Procedure: Irreversible electroporation (IRE)
* Device: NanoKnife


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Head and Neck Neoplasms diagnosed by positive biopsy or non-invasive criteria, Not suitable for surgical resection, Eastern Cooperative Oncology Group (ECOG) score of 0-1, A prothrombin time ratio > 50%, Platelet count > 80x10^9/L, Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure, Able to comprehend and willing to sign the written informed consent form (ICF), Have a life expectancy of at least 3 months. Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>irreversible electroporation with voltage in level A for Unresectable Head and Neck Neoplasms | Procedure: Irreversible electroporation (IRE)<br>* Irreversible Electroportion For Unresectable Head and Neck Neoplasms guide with ultrasound or/and CT.<br>* Other names: NanoKnife;Device: NanoKnife<br> <br> |
| Experimental: Group B<br>irreversible electroporation with voltage in level B for Unresectable Head and Neck Neoplasms | Procedure: Irreversible electroporation (IRE)<br>* Irreversible Electroportion For Unresectable Head and Neck Neoplasms guide with ultrasound or/and CT.<br>* Other names: NanoKnife;Device: NanoKnife<br> <br> |
| Experimental: Group C<br>irreversible electroporation with voltage in level C for Unresectable Head and Neck Neoplasms | Procedure: Irreversible electroporation (IRE)<br>* Irreversible Electroportion For Unresectable Head and Neck Neoplasms guide with ultrasound or/and CT.<br>* Other names: NanoKnife;Device: NanoKnife<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse events |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of lesions that show no sign of recurrence 12 months after IRE |  | 12 months | 
| Voltage (A minimum and maximum range of voltage for safe and effective IRE) | A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice. | 3 months | 
| Progress free disease (PFS) |  | 12 months | 
| Overall survival (OS) | Patients will be followed for 36 months after IRE for OS analyzed. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irreversible electroporation, Unresectable Head and Neck Neoplasms