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Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC)

Primary Purpose

Carcinoma, Hepatocellular

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Ablation with the NanoKnife Low Energy Direct Current (LEDC) System

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring HCC, Hepatocellular Carcinoma, Early Stage, Prospective, Multicenter, Irreversible Electroporation (IRE), Electroporation, Low Energy Direct Current, LEDC, Nonthermal ablation, NTIRE (nonthermal IRE), Ablation, Soft Tissue

Eligibility Criteria

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

Inclusion Criteria:

HCC diagnosed by positive biopsy or non-invasive criteria,
not suitable for surgical resection or transplantation,
have at least one, but less than or equal to 3 tumors,
of the tumour(s) identified, each tumor must be ≤ 3 cm in diameter,
Child-Pugh class A,
Eastern Cooperative Oncology Group (ECOG) score of 0,
American Society of Anaesthesiologists (ASA) score ≤ 3,
a prothrombin time ratio > 50%,
platelet count > 50x109/L,
ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
are able to comprehend and willing to sign the written informed consent form (ICF),
have a life expectancy of at least 3 months.

Exclusion Criteria:

eligible for surgical treatment or transplantation for HCC,
presence of vascular invasion or extrahepatic metastases,
received previous treatment for HCC,
HCC developed on an already transplanted liver,
cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
any active implanted device (eg Pacemaker),
women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Sites / Locations

L'institut de cancerologie Gustave Roussy
Hopital Beaujon
Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin
University of Pisa School of Medicine
Istituto Nazionale Tumori - Fondazione Pascale
Barcelona Clinic Liver Cancer Group, Hospital Clinic i Provincial de Barcelona

Outcomes

Primary Outcome Measures

Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.

Secondary Outcome Measures

Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.

Full Information

NCT ID

NCT01078415

First Posted

February 26, 2010

Last Updated

November 7, 2016

Sponsor

Angiodynamics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01078415

Brief Title

Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC)

Official Title

A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Angiodynamics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the NanoKnife LEDC System for the treatment of early-stage hepatocellular carcinoma (HCC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular

Keywords

HCC, Hepatocellular Carcinoma, Early Stage, Prospective, Multicenter, Irreversible Electroporation (IRE), Electroporation, Low Energy Direct Current, LEDC, Nonthermal ablation, NTIRE (nonthermal IRE), Ablation, Soft Tissue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Ablation with the NanoKnife Low Energy Direct Current (LEDC) System

Other Intervention Name(s)

System also known as:, * Low Energy Direct Current (LEDC) System, * HVP01 Electroporation System, * NanoKnife LEDC System, * NanoKnife IRE System

Intervention Description

90 pulses of 70 microseconds each in duration will be administered per electrode pair.

Primary Outcome Measure Information:

Title

Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.

Time Frame

30 days (+/- 3 days) post treatment

Secondary Outcome Measure Information:

Title

Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.

Time Frame

Immediately post treatment to 2 years post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HCC diagnosed by positive biopsy or non-invasive criteria, not suitable for surgical resection or transplantation, have at least one, but less than or equal to 3 tumors, of the tumour(s) identified, each tumor must be ≤ 3 cm in diameter, Child-Pugh class A, Eastern Cooperative Oncology Group (ECOG) score of 0, American Society of Anaesthesiologists (ASA) score ≤ 3, a prothrombin time ratio > 50%, platelet count > 50x109/L, ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure, are able to comprehend and willing to sign the written informed consent form (ICF), have a life expectancy of at least 3 months. Exclusion Criteria: eligible for surgical treatment or transplantation for HCC, presence of vascular invasion or extrahepatic metastases, received previous treatment for HCC, HCC developed on an already transplanted liver, cardiac insufficiency, ongoing coronary artery disease or arrhythmia, any active implanted device (eg Pacemaker), women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System, are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Riccardo Lencioni, MD

Organizational Affiliation

University of Pisa School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jordi Bruix, MD

Organizational Affiliation

Barcelona Clinic Liver Cancer (BCLC) Group of the University of Barcelona

Official's Role

Principal Investigator

Facility Information:

Facility Name

L'institut de cancerologie Gustave Roussy

City

Villejuif

State/Province

Ile-de-France

ZIP/Postal Code

94805

Country

France

Facility Name

Hopital Beaujon

City

Paris

ZIP/Postal Code

92110

Country

France

Facility Name

Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin

City

Magdeburg

ZIP/Postal Code

D-39120

Country

Germany

Facility Name

University of Pisa School of Medicine

City

Pisa

State/Province

Tuscany

ZIP/Postal Code

56124

Country

Italy

Facility Name

Istituto Nazionale Tumori - Fondazione Pascale

City

Naples

ZIP/Postal Code

80131

Country

Italy

Facility Name

Barcelona Clinic Liver Cancer Group, Hospital Clinic i Provincial de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

14667750

Citation

Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.

Results Reference

background

PubMed Identifier

15761078

Citation

Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.

Results Reference

background

PubMed Identifier

11592607

Citation

Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodes J; EASL Panel of Experts on HCC. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol. 2001 Sep;35(3):421-30. doi: 10.1016/s0168-8278(01)00130-1. No abstract available.

Results Reference

background

PubMed Identifier

16250051

Citation

Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.

Results Reference

background

PubMed Identifier

18477802

Citation

Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.

Results Reference

background

PubMed Identifier

11343235

Citation

Jonas S, Bechstein WO, Steinmuller T, Herrmann M, Radke C, Berg T, Settmacher U, Neuhaus P. Vascular invasion and histopathologic grading determine outcome after liver transplantation for hepatocellular carcinoma in cirrhosis. Hepatology. 2001 May;33(5):1080-6. doi: 10.1053/jhep.2001.23561.

Results Reference

background

PubMed Identifier

11391528

Citation

Yao FY, Ferrell L, Bass NM, Watson JJ, Bacchetti P, Venook A, Ascher NL, Roberts JP. Liver transplantation for hepatocellular carcinoma: expansion of the tumor size limits does not adversely impact survival. Hepatology. 2001 Jun;33(6):1394-403. doi: 10.1053/jhep.2001.24563.

Results Reference

background

PubMed Identifier

15665226

Citation

Lencioni R, Cioni D, Crocetti L, Franchini C, Pina CD, Lera J, Bartolozzi C. Early-stage hepatocellular carcinoma in patients with cirrhosis: long-term results of percutaneous image-guided radiofrequency ablation. Radiology. 2005 Mar;234(3):961-7. doi: 10.1148/radiol.2343040350. Epub 2005 Jan 21.

Results Reference

background

PubMed Identifier

10573522

Citation

Llovet JM, Fuster J, Bruix J. Intention-to-treat analysis of surgical treatment for early hepatocellular carcinoma: resection versus transplantation. Hepatology. 1999 Dec;30(6):1434-40. doi: 10.1002/hep.510300629.

Results Reference

background

PubMed Identifier

12360427

Citation

Yao FY, Bass NM, Nikolai B, Davern TJ, Kerlan R, Wu V, Ascher NL, Roberts JP. Liver transplantation for hepatocellular carcinoma: analysis of survival according to the intention-to-treat principle and dropout from the waiting list. Liver Transpl. 2002 Oct;8(10):873-83. doi: 10.1053/jlts.2002.34923.

Results Reference

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Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC)

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