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

Primary Purpose

Metastatic Liver Cancer, Cholangiocarcinoma, Neoplasm Metastasis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Irreversible electroporation (IRE)
Sponsored by
Azienda Ospedaliera di Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Liver Cancer focused on measuring Laparotomic surgery, Laparoscopic surgery, Percutaneos tumour ablation, Irreversible electroporation (IRE)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Azienda Ospedaliera di PadovaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IRE

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety
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

Full Information

First Posted
September 27, 2011
Last Updated
July 17, 2012
Sponsor
Azienda Ospedaliera di Padova
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1. Study Identification

Unique Protocol Identification Number
NCT01442324
Brief Title
Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera di Padova

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Liver Cancer, Cholangiocarcinoma, Neoplasm Metastasis
Keywords
Laparotomic surgery, Laparoscopic surgery, Percutaneos tumour ablation, Irreversible electroporation (IRE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IRE
Arm Type
Experimental
Arm Description
Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.
Intervention Type
Procedure
Intervention Name(s)
Irreversible electroporation (IRE)
Other Intervention Name(s)
NanoKnife™ System, AngioDynamics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma.
Description
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.
Time Frame
1 month post-intervention
Secondary Outcome Measure Information:
Title
Safety
Description
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 Frame
30 days post-intervention
Title
Time to in situ recurrence
Time Frame
2 years post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Umberto Cillo, MD
Phone
+390498218624
Email
cillo@unipd.it
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Vitale, MD
Phone
+390498218624
Email
alessandro.vitale@unipd.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umberto Cillo, MD
Organizational Affiliation
Azienda Ospedaliera di Padova
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alessandro Vitale, MD
Organizational Affiliation
Azienda Ospedaliera di Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera di Padova
City
Padova
State/Province
PD
ZIP/Postal Code
I-35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umberto Cillo, MD
Phone
+390498218624
Email
ciilo@unipd.it
First Name & Middle Initial & Last Name & Degree
Alessandro Vitale, MD
Phone
+390498218624
Email
alessandro.vitale@unipd.it
First Name & Middle Initial & Last Name & Degree
Umberto Cillo, MD
First Name & Middle Initial & Last Name & Degree
Alessandro Vitale, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20142349
Citation
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.
Results Reference
background
PubMed Identifier
17668936
Citation
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.
Results Reference
background
PubMed Identifier
17668933
Citation
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.
Results Reference
background
PubMed Identifier
17989772
Citation
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.
Results Reference
background
Links:
URL
http://www.fegatochirurgia.com
Description
Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)

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

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