Status:
COMPLETED
Pilot-study: Non-thermal Ablation Using Irreversible Electroporation to Treat Colorectal Liver Metastases
Lead Sponsor:
Dr. M.R. Meijerink
Collaborating Sponsors:
Amsterdam UMC, location VUmc
Conditions:
Colorectal Liver Metastases
Metastatic Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Irreversible electroporation is a new, minimal-invasive image-guided treatment to treat tumors near or around vulnerable structures, such as central liver tumors. To investigate the safety and effica...
Detailed Description
This pilot-study is designed to determine the safety of IRE using the NanoKnife on colorectal liver metastases. Secondary, feasibility, histological effect on the ablated cells and exact shape and siz...
Eligibility Criteria
Inclusion
- Histological or cytological documentation of primary colorectal tumor
- Liver metastases visible on FDG PET-CT or ceCT, size ≤ 3,5 cm and eligible for resection
- Resectability re-confirmed per-operatively by US
- Age \> 18 years
- WHO performance status 0 - 2
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion:
- Hemoglobin ≥ 5.6 mmol/L;
- Absolute neutrophil count (ANC) ≥ 1,500/mm3;
- Platelet count ≥ 100\*109/l;
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
- ALT and AST ≤ 2.5 x ULN
- Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance ³ 50 ml/min;
- Prothrombin time or INR \< 1.5 x ULN;
- Activated partial thromboplastin time \< 1.25 x ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician).
- Written informed consent.
Exclusion
- Lesion \> 3,5 cm size
- History of epilepsy
- History of cardiac disease:
- Congestive heart failure \>NYHA class 2;
- Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening);
- Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers are permitted).
- Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen.
- Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites)
- Uncontrolled infections (\> grade 2 NCI-CTC version 3.0).
- Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment.
- Immunotherapy ≤ 6 weeks prior to the procedure
- Chemotherapy ≤ 12 weeks prior to the procedure
- Radiotherapy, RFA or MWA treatment of target lesions prior to resection
- Concomitant use of anti-convulsive and anti-arrhythmic drugs other than beta blockers.
- Allergy to contrast media
- Any implanted stimulation device
- Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01799044
Start Date
November 1 2012
End Date
September 1 2013
Last Update
December 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VU University Medical Center
Amsterdam, North Holland, Netherlands, 1081HV