Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma
|ClinicalTrials.gov Identifier: NCT01442324|
Recruitment Status : Unknown
Verified July 2012 by Prof. Umberto Cillo, Azienda Ospedaliera di Padova.
Recruitment status was: Recruiting
First Posted : September 28, 2011
Last Update Posted : July 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Liver Cancer Cholangiocarcinoma Neoplasm Metastasis||Procedure: Irreversible electroporation (IRE)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2011|
|Estimated Primary Completion Date :||September 2012|
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)
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.
- Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma. [ Time Frame: 1 month post-intervention ]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.
- Safety [ Time Frame: 30 days post-intervention ]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 [ Time Frame: 2 years post-intervention ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442324
|Contact: Umberto Cillo, MDemail@example.com|
|Contact: Alessandro Vitale, MDfirstname.lastname@example.org|
|Azienda Ospedaliera di Padova||Recruiting|
|Padova, PD, Italy, I-35128|
|Contact: Umberto Cillo, MD +390498218624 email@example.com|
|Contact: Alessandro Vitale, MD +390498218624 firstname.lastname@example.org|
|Principal Investigator: Umberto Cillo, MD|
|Sub-Investigator: Alessandro Vitale, MD|
|Study Chair:||Umberto Cillo, MD||Azienda Ospedaliera di Padova|
|Principal Investigator:||Alessandro Vitale, MD||Azienda Ospedaliera di Padova|