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Evaluation of Tumor Ablation Effects by Irreversible Electroporation for Patients With Malignant Liver Tumors

Primary Purpose

Malignant Liver Tumors

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
irreversible electroporation
nanoknife AngioDynamics US Ltd
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Liver Tumors focused on measuring hepatocellular carcinoma, irreversible electroporation, liver cancer

Eligibility Criteria

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

Inclusion Criteria:

  • The diagnosis of HCC or other cancers with hepatic metastatic with pathologic proven.
  • The diagnosis of HCC will be made by pathology / cytology or according to the AASLD(2010) diagnostic criteria. In brief, Nodules larger than 1 cm found on ultrasound screening of a cirrhotic liver should be investigated further with either 4-phase multidetector CT scan or dynamic contrast enhanced MRI. If the appearances are typical of HCC (i.e., hypervascular in the arterial phase with washout in the portal venous or delayed phase), the lesion should be treated as HCC. If the findings are not characteristic or the vascular profile is not typical, a second contrast enhanced study with the other imaging modality should be performed, or the lesion should be biopsied. Biopsies of small lesions should be evaluated by expert pathologists. Tissue that is not clearly HCC should be stained with all the available markers including CD34, CK7, glypican 3, HSP-70, and glutamine synthetase to improve diagnostic accuracy.
  • Suitable for surgical resection, but the distance between tumors and preserved vessels is less than 5 mm. Adequate safe margin can not be obtained.
  • There are at least one tumor, but less than or equal to 3 tumors,
  • Each tumor must be ≤ 5 cm in diameter,
  • Child-Pugh class A-B,
  • Eastern Cooperative Oncology Group (ECOG) score of 0-1,
  • American Society of Anaesthesiologists (ASA) score ≤ 3,
  • Platelet count ≥ 100 K/Μl
  • Total bilirubin ≦ 2 mg/dL
  • ALT and AST < 5 x upper limit of normal
  • PT-INR ≦ 2.0, or PT < 6 seconds above control
  • Serum creatinine ≦ 1.5 x upper limit of normal
  • Prior Informed Consent Form
  • Life expectancy of at least 3 months.

Exclusion Criteria:

  • Congestive heart failure >New York Heart Association (NYHA) class 2
  • Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed)
  • Cardiac arrhythmias (>Grade 2 NCI-CTCAE Version 3.0) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker
  • Uncontrolled hypertension
  • Any active metal implanted device (eg Pacemaker),
  • Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
  • Received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ IRE System,
  • Known history of HIV infection
  • Concurrent primary extrahepatic cancer

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IRE for tumor before tumor resection

Arm Description

Outcomes

Primary Outcome Measures

Complete treatment

Secondary Outcome Measures

adverse effect

Full Information

First Posted
December 4, 2013
Last Updated
December 12, 2013
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02010801
Brief Title
Evaluation of Tumor Ablation Effects by Irreversible Electroporation for Patients With Malignant Liver Tumors
Official Title
Evaluation of Tumor Ablation Effects by Irreversible Electroporation for Patients With Malignant Liver Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70%to 85%) of patients present with advanced or unresectable disease. In contrast, small liver cancers can be cured with an appreciable frequency. Five-year disease-free survival exceeding 50% has been reported for surgical resection, and for the inoperable patients who do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an alternative curative therapy. However, the main drawback of RFA is its limitation to tumor size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels, could not be ablated completely. Irreversible electroporation (IRE), developed and manufactured by AngioDynamics US Ltd, can ablate tumor by fenestrating the cancer cell membrane by electric pulse. The anti-tumor effect does not result from thermotherapy, so is also not diminished by adjacent vessels. Several pre-clinical studies have already demonstrated IRE is a safe and effective treatment for live cancers. The system has received CE mark approval in 2008 and FDA approval in 2010. However, there is no experience in using IRE fro tumor ablation in Taiwan. In this study, the investigators will perform intraoperative IRE for the patients with liver cancers who are scheduled to receive hepatectomy in our hospital, and the investigators will evaluate the ablate effect of tumors on specimens, and the effect of adjacent vessels. The investigators will appraisal the clinical feasibility and advantage of the system by this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Liver Tumors
Keywords
hepatocellular carcinoma, irreversible electroporation, liver cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
IRE for tumor before tumor resection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
irreversible electroporation
Other Intervention Name(s)
nanoknife
Intervention Type
Device
Intervention Name(s)
nanoknife AngioDynamics US Ltd
Primary Outcome Measure Information:
Title
Complete treatment
Time Frame
1 month later
Secondary Outcome Measure Information:
Title
adverse effect
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The diagnosis of HCC or other cancers with hepatic metastatic with pathologic proven. The diagnosis of HCC will be made by pathology / cytology or according to the AASLD(2010) diagnostic criteria. In brief, Nodules larger than 1 cm found on ultrasound screening of a cirrhotic liver should be investigated further with either 4-phase multidetector CT scan or dynamic contrast enhanced MRI. If the appearances are typical of HCC (i.e., hypervascular in the arterial phase with washout in the portal venous or delayed phase), the lesion should be treated as HCC. If the findings are not characteristic or the vascular profile is not typical, a second contrast enhanced study with the other imaging modality should be performed, or the lesion should be biopsied. Biopsies of small lesions should be evaluated by expert pathologists. Tissue that is not clearly HCC should be stained with all the available markers including CD34, CK7, glypican 3, HSP-70, and glutamine synthetase to improve diagnostic accuracy. Suitable for surgical resection, but the distance between tumors and preserved vessels is less than 5 mm. Adequate safe margin can not be obtained. There are at least one tumor, but less than or equal to 3 tumors, Each tumor must be ≤ 5 cm in diameter, Child-Pugh class A-B, Eastern Cooperative Oncology Group (ECOG) score of 0-1, American Society of Anaesthesiologists (ASA) score ≤ 3, Platelet count ≥ 100 K/Μl Total bilirubin ≦ 2 mg/dL ALT and AST < 5 x upper limit of normal PT-INR ≦ 2.0, or PT < 6 seconds above control Serum creatinine ≦ 1.5 x upper limit of normal Prior Informed Consent Form Life expectancy of at least 3 months. Exclusion Criteria: Congestive heart failure >New York Heart Association (NYHA) class 2 Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed) Cardiac arrhythmias (>Grade 2 NCI-CTCAE Version 3.0) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker Uncontrolled hypertension Any active metal implanted device (eg Pacemaker), Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, Received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ IRE System, Known history of HIV infection Concurrent primary extrahepatic cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai-Wen Huang, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan

12. IPD Sharing Statement

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Evaluation of Tumor Ablation Effects by Irreversible Electroporation for Patients With Malignant Liver Tumors

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