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

This study is currently recruiting participants.
Verified July 2012 by Azienda Ospedaliera di Padova
Sponsor:
Information provided by (Responsible Party):
Prof. Umberto Cillo, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier:
NCT01442324
First received: September 27, 2011
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Metastatic Liver Cancer
Cholangiocarcinoma
Neoplasm Metastasis
 Procedure: Irreversible electroporation (IRE)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera di Padova:

Primary Outcome Measures:
  • Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma. [ Time Frame: 1 month post-intervention ] [ Designated as safety issue: No ]
    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:
  • Safety [ Time Frame: 30 days post-intervention ] [ Designated as safety issue: Yes ]
    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.

  • Time to in situ recurrence [ Time Frame: 2 years post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: February 2011
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442324

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

Locations
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
Study Chair: Umberto Cillo, MD Azienda Ospedaliera di Padova
Principal Investigator: Alessandro Vitale, MD Azienda Ospedaliera di Padova
  More Information

Additional Information:
Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Prof. Umberto Cillo, Director of the Hepatobiliary Surgery and Liver Transplantation Unit, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT01442324     History of Changes
Other Study ID Numbers: 2252P
Study First Received: September 27, 2011
Last Updated: July 17, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera di Padova:
Laparotomic surgery
Laparoscopic surgery
Percutaneos tumour ablation
Irreversible electroporation (IRE)

Additional relevant MeSH terms:
Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Cholangiocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Liver Diseases
Neoplastic Processes
Pathologic Processes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 19, 2013