Metastatic Liver CancerNCT01442324
Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma
A study testing Irreversible electroporation (IRE) in people with Metastatic Liver Cancer and Cholangiocarcinoma, run by Azienda Ospedaliera di Padova at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Liver Cancer, Cholangiocarcinoma, Neoplasm Metastasis
- What is being tested?
- Irreversible electroporation (IRE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera di Padova
Padova, PD, I-35128
Umberto Cillo, MD, +390498218624, ciilo@unipd.it
Alessandro Vitale, MD, +390498218624, alessandro.vitale@unipd.it
About this study
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
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.
Read the 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.
- Being tested
- Irreversible electroporation (IRE)
- Keywords
- Laparotomic surgery, Laparoscopic surgery, Percutaneos tumour ablation, Irreversible electroporation (IRE)
- Medical subject headings
- Liver Neoplasms, Cholangiocarcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible electroporation (IRE)Procedure or surgery
Also called NanoKnife™ System, AngioDynamics
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.
| Study group | Role | What they receive |
|---|---|---|
| IRE | Experimental | Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation. Receives: Procedure: Irreversible electroporation (IRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month post-intervention
Secondary outcomes (2)
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.
Measured: 30 days post-intervention
Time to in situ recurrence
Measured: 2 years post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metastatic Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Umberto Cillo, Azienda Ospedaliera di Padova
- Investigators
- Umberto Cillo, MD, Study chair, Azienda Ospedaliera di PadovaAlessandro Vitale, MD, Principal investigator, Azienda Ospedaliera di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442324
- Sponsor's protocol ID
- 2252P
- Status last verified
- Jul 2012
- First submitted
- 27 Sep 2011
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20142349Onik 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.
PubMed 17668936Esser 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.
PubMed 17668933Al-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.
PubMed 17989772
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01442324
- Acronym / sponsor ID
- 2252P
- Keywords
- Laparotomic surgery, Laparoscopic surgery, Percutaneos tumour ablation, Irreversible electroporation (IRE)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Sep 2012 (estimated)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IRE | Experimental | Procedure: Irreversible electroporation (IRE)Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irreversible electroporation (IRE)Also: NanoKnife™ System, AngioDynamicsNeedle-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. | Procedure or surgery | IRE |
Primary outcome
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.
2 secondary outcomes
Safety
Time frame: 30 days post-intervention
Time to in situ recurrence
Time frame: 2 years post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
- Background: PubMed 20142349Ball 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.
- Background: PubMed 17668936Onik 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.
- Background: PubMed 17668933Esser 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.
- Background: PubMed 17989772Al-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.
- Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umberto Cillo, MD study chair
Azienda Ospedaliera di Padova
Alessandro Vitale, MD principal investigator
Azienda Ospedaliera di Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irreversible electroporation (IRE) in people with Metastatic Liver Cancer and Cholangiocarcinoma, run by Azienda Ospedaliera di Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umberto Cillo, MD (+390498218624, cillo@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma. (time frame: 1 month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01442324, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.