NCT01442324

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

1.6 years

First QC Date

September 27, 2011

Last Update Submit

July 17, 2012

Conditions

Metastatic Liver CancerCholangiocarcinomaNeoplasm Metastasis

Keywords

Laparotomic surgeryLaparoscopic surgeryPercutaneos tumour ablationIrreversible electroporation (IRE)

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma.

    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 Outcomes (2)

  • Safety

    30 days post-intervention

  • Time to in situ recurrence

    2 years post-intervention

Study Arms (1)

IRE

EXPERIMENTAL

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)

Interventions

Irreversible electroporation (IRE)PROCEDURE

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.

Also known as: NanoKnife™ System, AngioDynamics
IRE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera di Padova

Padua, PD, I-35128, Italy

RECRUITING

Related Publications (4)

  • Ball C, Thomson KR, Kavnoudias H. Irreversible electroporation: a new challenge in "out of operating theater" anesthesia. Anesth Analg. 2010 May 1;110(5):1305-9. doi: 10.1213/ANE.0b013e3181d27b30. Epub 2010 Feb 8.

    PMID: 20142349BACKGROUND

  • Onik G, Mikus P, Rubinsky B. Irreversible electroporation: implications for prostate ablation. Technol Cancer Res Treat. 2007 Aug;6(4):295-300. doi: 10.1177/153303460700600405.

    PMID: 17668936BACKGROUND

  • Esser AT, Smith KC, Gowrishankar TR, Weaver JC. Towards solid tumor treatment by irreversible electroporation: intrinsic redistribution of fields and currents in tissue. Technol Cancer Res Treat. 2007 Aug;6(4):261-74. doi: 10.1177/153303460700600402.

    PMID: 17668933BACKGROUND

  • Al-Sakere B, Andre F, Bernat C, Connault E, Opolon P, Davalos RV, Rubinsky B, Mir LM. Tumor ablation with irreversible electroporation. PLoS One. 2007 Nov 7;2(11):e1135. doi: 10.1371/journal.pone.0001135.

    PMID: 17989772BACKGROUND

Related Links

MeSH Terms

Conditions

Liver NeoplasmsCholangiocarcinomaNeoplasm Metastasis

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesInvestigative TechniquesElectrochemical Techniques

Study Officials

  • Umberto Cillo, MD

    Azienda Ospedaliera di Padova

    STUDY CHAIR

  • Alessandro Vitale, MD

    Azienda Ospedaliera di Padova

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Umberto Cillo, MD

CONTACT

+390498218624cillo@unipd.it

Alessandro Vitale, MD

CONTACT

+390498218624alessandro.vitale@unipd.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Hepatobiliary Surgery and Liver Transplantation Unit

Study Record Dates

First Submitted

September 27, 2011

First Posted

September 28, 2011

Study Start

February 1, 2011

Primary Completion

September 1, 2012

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

IT(1)