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Pilot-study: Non-thermal Ablation Using Irreversible Electroporation to Treat Colorectal Liver Metastases (IRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799044
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : September 4, 2013
Sponsor:
Collaborator:
VU University Medical Center
Information provided by (Responsible Party):
Dr. M.R. Meijerink, VU University Medical Center

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 efficacy of IRE in the treatment of colorectal liver metastases, patients with resectable colorectal liver metastases undergo IRE and resection of the metastases in the same session. After resection, the specimen is examined macroscopically to determine vitality using a specific vitality staining (triphenyl-tetrazoliumchloride) and to visualize the exact ablation zone. Subsequently, histopathologic examination is used to determine type of cell death and the microscopic ablation zone.

The investigators hypothesize that IRE is a safe effective method to treat colorectal liver metastasis and that cell damage and cell death is demonstrated as soon as 1 hour after the procedure.


Condition or disease Intervention/treatment Phase
Colorectal Liver Metastases Metastatic Liver Disease Device: Irreversible electroporation (IRE) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot-study: Non-thermal Ablation Using Irreversible Electroporation (IRE) to Treat Colorectal Liver Metastases - "Ablate and Resect"
Study Start Date : November 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: Irreversible electroporation
Single arm study: Irreversible electroporation of colorectal liver metastasis
Device: Irreversible electroporation (IRE)
Tumor ablation with irreversible electroporation with the NanoKnife
Other Names:
  • IRE
  • NanoKnife




Primary Outcome Measures :
  1. Safety [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 week ]
    Safety using Common terminology Criteria for Adverse Events (CTCAE). Since the ablated tissue will be resected we expect procedure-related complications to occur mainly during the procedure.


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 1 year ]
    Cell death of CRLM after IRE is demonstrated macroscopically by using vitality-staining with triphenyl-tetrazoliumchloride (TTC). Since and shape of the ablation zone is assessed. Immunohistologic examination is used to more specifically assess microscopic cell damage and vessel wall damage. Apoptotic markers are used.


Other Outcome Measures:
  1. Feasibility [ Time Frame: 1 year ]
    The investigators hypothesize that it will initially take several replacements before adequate positioning is obtained. It is suspected that placement of the electrodes will become easier in the course of the study and that procedure time will decrease (expressed in learning curve).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799044


Locations
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Netherlands
VU University Medical Center
Amsterdam, Noord-Holland, Netherlands, 1081HV
Sponsors and Collaborators
Dr. M.R. Meijerink
VU University Medical Center
Investigators
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Principal Investigator: Martijn R Meijerink, MD, PhD VU University Medical Center
Principal Investigator: Petrousjka M van den Tol, MD, PhD VU University Medical Center
Study Director: C van Kuijk, Prof. Dr. VU University Medical Center, head of department of radiology
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Responsible Party: Dr. M.R. Meijerink, Dr., VU University Medical Center
ClinicalTrials.gov Identifier: NCT01799044    
Other Study ID Numbers: NL 41089.029.12 COLDFIRE
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013
Keywords provided by Dr. M.R. Meijerink, VU University Medical Center:
Irreversible electroporation
IRE
Electroporation
Colorectal liver metastases
CRLM
Safety
Feasibility
Efficacy
Single-center
Low Energy Direct Current
Ablate-and-resect
Nonthermal ablation
Ablation
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Liver Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site