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

NCT01799044 | Completed Phase 1 DMC

• 1 other identifier: NL 41089.029.12 COLDFIRE
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Liver Metastases; Metastatic Liver Disease

Keywords

Irreversible electroporation; IRE; Electroporation; Colorectal liver metastases; CRLM; Safety; Feasibility; Efficacy; Single-center; Low Energy Direct Current; Ablate-and-resect; Nonthermal ablation; Ablation

Outcome Measures

Primary Outcomes (1)

• Safety

  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.

  participants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary Outcomes (1)

• Efficacy

  1 year

Other Outcomes (1)

• Feasibility

  1 year

Study Arms (1)

Irreversible electroporation

EXPERIMENTAL

Single arm study: Irreversible electroporation of colorectal liver metastasis

Device: Irreversible electroporation (IRE)

Interventions

Irreversible electroporation (IRE) DEVICE

Tumor ablation with irreversible electroporation with the NanoKnife

Also known as: IRE, NanoKnife

Irreversible electroporation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. M.R. Meijerink: lead
• Amsterdam UMC, location VUmc: collaborator

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081HV, Netherlands

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Martijn R Meijerink, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Petrousjka M van den Tol, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• C van Kuijk, Prof. Dr.

  VU University Medical Center, head of department of radiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Model Details: Prospective ablate and resect trial where 10 patients with resecatble colorectal liver metastases were treated with irrevrsible electroporation approximately 2 hours before the tumors were resected.

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 26, 2013
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

NL (1)