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Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT01442324
Recruitment Status : Unknown
Verified July 2012 by Prof. Umberto Cillo, Azienda Ospedaliera di Padova.
Recruitment status was:  Recruiting
First Posted : September 28, 2011
Last Update Posted : July 18, 2012
Sponsor:
Information provided by (Responsible Party):
Prof. Umberto Cillo, Azienda Ospedaliera di Padova

Study Description
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Brief Summary:
Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.

Condition or disease Intervention/treatment Phase
Metastatic Liver Cancer Cholangiocarcinoma Neoplasm Metastasis Procedure: Irreversible electroporation (IRE) Not Applicable

Detailed Description:

Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.

This pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic IRE in the treatment of neoplastic nodules in the liver, with particular reference to metastatic liver cancer and cholangiocarcinoma, where the current therapeutic arsenal is inadequate or counter-indicated.

To perform the IRE procedure the IRE NanoKnife™ System (AngioDynamics) will be used.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Studio Clinico Pilota Con Uso di Elettroporazione Irreversibile (IRE) Nel Trattamento di Lesioni Neoplastiche Epatiche Con Localizzazione ad accessibilità Limitata o ad Alto Rischio
Study Start Date : February 2011
Estimated Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: IRE
Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.
 Procedure: Irreversible electroporation (IRE)
Needle-like electrodes are inserted through the liver and in the lesion without exceeding its deepest margin, at which point the IRE NanoKnife™ System (AngioDynamics) is started.
Other Names:
  • NanoKnife™ System
  • AngioDynamics


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma. [ Time Frame: 1 month post-intervention ]
    The primary measurement parameter for the purposes of this determination is the evaluation of the response of IRE treated lesions according to modified RECIST criteria using CT images or magnetic resonance imaging performed 20 to 40 days after treatment.


Secondary Outcome Measures :
  1. Safety [ Time Frame: 30 days post-intervention ]
    The safety endpoint will be the occurrence of serious adverse events related to treatment within 30 days of treatment. All adverse events will be classified according to CTCAE version 3.0 criteria.

  2. Time to in situ recurrence [ Time Frame: 2 years post-intervention ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • older than 18 years,
  • male or female,
  • diagnosis of secondary liver cancer or cholangiocarcinoma based on positive biopsy or noninvasive criteria,
  • presence of at least one lesion untreatable by surgical resection or ablation for microwave or radio frequency,
  • the target nodule must have a diameter of ≤ 5 cm
  • ECOG score(Eastern Cooperative Oncology Group) 0,
  • ASA score (American Society of Anesthesiologists) ≤ 3,
  • prothrombin time ratio >50%
  • platelet count >50x10^9/l,
  • patient's ability to discontinue anticoagulant and antiplatelet therapy for seven days before and seven days after surgery with NanoKnife™,
  • ability to understand and willingness to sign the written informed consent form (ICF),
  • life expectancy of at least 3 months.

Exclusion Criteria:

  • presence of more than 5 liver lesions,
  • previous treatment of the target nodule,
  • patient received systemic chemotherapy within 30 days of treatment with the IRE NanoKnife™,
  • heart failure, coronary artery disease or arrhythmia in progress, active implantable devices (eg pacemaker),
  • pregnant women or women of childbearing potential not using an acceptable method of contraception,
  • patient undergoing treatment with an investigational drug within 30 days of treatment with the IRE NanoKnife™,
  • in the opinion of the researcher, anyone who can not follow the calendar of visits and assessments of the Protocol.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442324


Contacts
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Contact: Umberto Cillo, MD +390498218624 cillo@unipd.it
Contact: Alessandro Vitale, MD +390498218624 alessandro.vitale@unipd.it

Locations
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Italy
Azienda Ospedaliera di Padova Recruiting
Padova, PD, Italy, I-35128
Contact: Umberto Cillo, MD    +390498218624    ciilo@unipd.it   
Contact: Alessandro Vitale, MD    +390498218624    alessandro.vitale@unipd.it   
Principal Investigator: Umberto Cillo, MD         
Sub-Investigator: Alessandro Vitale, MD         
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Investigators
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Study Chair: Umberto Cillo, MD Azienda Ospedaliera di Padova
Principal Investigator: Alessandro Vitale, MD Azienda Ospedaliera di Padova
More Information
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Additional Information:

Publications:

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Responsible Party: Prof. Umberto Cillo, Director of the Hepatobiliary Surgery and Liver Transplantation Unit, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT01442324    
Other Study ID Numbers: 2252P
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012
Keywords provided by Prof. Umberto Cillo, Azienda Ospedaliera di Padova:
Laparotomic surgery
Laparoscopic surgery
Percutaneos tumour ablation
Irreversible electroporation (IRE)
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Cholangiocarcinoma
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type