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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

September 27, 2011
July 17, 2012
February 2011
September 2012   (final data collection date for primary outcome measure)
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.
Effectiveness of IRE for the treatment of metastatic liver cancer nodules. [ 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.
Complete list of historical versions of study NCT01442324 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma
Studio Clinico Pilota Con Uso di Elettroporazione Irreversibile (IRE) Nel Trattamento di Lesioni Neoplastiche Epatiche Con Localizzazione ad accessibilità Limitata o ad Alto Rischio

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.

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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Liver Cancer
  • Cholangiocarcinoma
  • Neoplasm Metastasis
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
Experimental: IRE
Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.
Intervention: Procedure: Irreversible electroporation (IRE)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
Not Provided
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Umberto Cillo, MD +390498218624 cillo@unipd.it
Contact: Alessandro Vitale, MD +390498218624 alessandro.vitale@unipd.it
Italy
 
NCT01442324
2252P
Yes
Prof. Umberto Cillo, Azienda Ospedaliera di Padova
Azienda Ospedaliera di Padova
Not Provided
Study Chair: Umberto Cillo, MD Azienda Ospedaliera di Padova
Principal Investigator: Alessandro Vitale, MD Azienda Ospedaliera di Padova
Azienda Ospedaliera di Padova
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP