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

July 17, 2012 updated by: Prof. Umberto Cillo, Azienda Ospedaliera di Padova

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • PD
      • Padova, PD, Italy, I-35128
        • Recruiting
        • Azienda Ospedaliera di Padova
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days post-intervention
Time to in situ recurrence
Time Frame: 2 years post-intervention
2 years post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera di Padova

Investigators

  • Principal Investigator: Alessandro Vitale, MD, Azienda Ospedaliera di Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

September 27, 2011

First Posted (Estimate)

September 28, 2011

Study Record Updates

Last Update Posted (Estimate)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2252P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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