Pilot-study: Investigation of the safety of irreversible electroporation (IRE) as novel treatment for colorectal liver metastases - a phase I clinical study

Completed

Conditions: Colorectal liver metastases
synonyme: metastases in the liver derived from colorectal carcinoma
10019815
10027476
10019818

Registration Number: NL-OMON37255

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Screening must be performed no longer than 4 weeks prior to study inclusion. Subjects are eligible if they meet the following criteria:
* Histological or cytological documentation of primary colorectal tumor
* Liver metastases visible on FDG PET-CT or contrast-enhanced CT, size * 3,5 cm.
* Resectability (re)confirmed by intraoperative US
* Age 18 years or older
* 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

Subjects who meet the following criteria at the time of screening will be excluded:
* Lesion > 3,5 cm
* 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)
* History of epilepsy
* Uncontrolled hypertension. Blood pressure must be *160/95 mmHg at the time of screening without medication or on a stable antihypertensive regimen.
* 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 within 12 weeks before surgery
* Radiotherapy, RFA or MWT treatment of target lesions prior to resection
* Concomitant use of dexamethasone, anti-convulsants and anti-arrhythmic drugs.
* Severe allergy for contrast media not controlled with premedication.
* Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the safety of the IRE procedure using the NanoKnife. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are feasibility (including procedure time), size and shape<br /><br>of ablated area and the extent of cellular damage and apoptosis. </p><br>