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

Cholangiocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01442324
• Other study ID #: 2252P
• Status: Recruiting
• Phase: N/A
• First received: September 27, 2011
• Last updated: July 17, 2012
• Start date: February 2011

Study information

• Verified date: July 2012
• Source: Azienda Ospedaliera di Padova
• Contact: Umberto Cillo, MD
• Phone: +390498218624
• Email: cillo[@]unipd.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Liver Neoplasms
• Metastatic Liver Cancer
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera di Padova	Padova	PD

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Al-Sakere B, André 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. — View 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. — View 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. — View Citation

Onik G, Mikus P, Rubinsky B. Irreversible electroporation: implications for prostate ablation. Technol Cancer Res Treat. 2007 Aug;6(4):295-300. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	30 days post-intervention	Yes
Secondary	Time to in situ recurrence		2 years post-intervention	No

External Links

•   Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)