International Study on Treatment of Patients With Metastatic Colorectal Liver Lesions Patients With IRE

NCT ID: NCT07191548

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2029-02-28

Brief Summary

Procedural data will be recorded from patients with liver metastases from colorectal cancer who have received at least one course of systemic chemotherapy and who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation.

Conditions

Colorectal Adenocarcinoma Metastatic in the Liver; Liver Ablation; Liver Cancer, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Use of NanoKnife System for ablation of metastatic colorectal lesions

Group Type: EXPERIMENTAL

Irreversible Electroporation

Intervention Type: DEVICE

Irreversible electroporation (IRE) is a procedure which involves the passage of short intense electrical pulses between probes to destabilize cell membranes by creating "nanopores" which leads to cell destabilisation and cell death.

IRE can be used to selectively damage cancerous cells whilst sparing adjacent supporting connective tissue in vessels and bile ducts allowing a more targeted treatment compared to other types of ablation. IRE also avoids the heat-sink phenomenon which compromises the effectiveness of thermal ablation and possibly reduces the risks of biliary injury.

Interventions

Irreversible Electroporation

Irreversible electroporation (IRE) is a procedure which involves the passage of short intense electrical pulses between probes to destabilize cell membranes by creating "nanopores" which leads to cell destabilisation and cell death.

IRE can be used to selectively damage cancerous cells whilst sparing adjacent supporting connective tissue in vessels and bile ducts allowing a more targeted treatment compared to other types of ablation. IRE also avoids the heat-sink phenomenon which compromises the effectiveness of thermal ablation and possibly reduces the risks of biliary injury.

Intervention Type: DEVICE

Other Intervention Names

nanoknife

Eligibility Criteria

Inclusion Criteria

• Patients aged 18 years and over, able to provide informed consent and with histological confirmation of a diagnosis of colorectal cancer from primary tumour.
• Liver lesions demonstrating radiological characteristics (on magnetic resonance scan) of colorectal hepatic metastases without requirement for biopsy. In the setting of an intact liver, patients with up to four metastases ≤ 4cm in size are eligible for inclusion. In the setting of proposed resection plus ablation, up to two metastases ≤ 4cm in size. In the setting of recurrence after prior hepatectomy up to two metastases ≤ 4cm in size.
• Eastern Co-operative Oncology Group (ECOG) Score ≤ 2.
• Rockwood Frailty Score ≤ 3.
• Serum bilirubin < 30 µmol/L.
• Serum creatinine < 150 µmol/L.
• Up to two lung metastases (< 2cm in size permitted at enrolment).
• Prior treatment with at least one course of systemic chemotherapy (± biologic agent) mandated. Chemotherapy protocol is not specified and is at clinician discretion.
• Primary rectal tumour can remain in situ treated with radiotherapy/chemoradiotherapy according to tumour board recommendations. Primary colonic tumour can remain in situ.
• No prior hepatic tumour ablation

Exclusion Criteria

• Patients involved in other research studies.
• Inability to give informed consent.
• Patients who are pregnant.
• Accepted exclusions to IRE from consensus criteria including:
• Platelet count < 50x109 U/L.
• International normalised ratio (INR) for blood clotting > 1.7.
• Prior hepatic tumour ablation.

Cardiovascular fitness related exclusions:

• History of ventricular arrhythmia.
• Implanted pacemaker or defibrillator.
• Congestive cardiac failure NYHA Class ≥ 3.

Tumour-related exclusions:

• Tumour ≥ 4 cm in size.
• Advanced multi-site metastatic cancer (any of the following): peritoneal metastases (M1c), bone metastases, > 2 lung metastases, all segment involvement multiple liver metastases.
• Jaundice (serum bilirubin > 30 µmol/L).
• MDT/tumour recommends use of thermal ablation instead of IRE for any given lesion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Angiodynamics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ajith Siriwardena, MD FRCS

Role: PRINCIPAL_INVESTIGATOR

Manchester Royal Infirmiary

Locations

Manchester Royal Infirmiary

Manchester, , United Kingdom

Countries

United Kingdom

Central Contacts

Mitchell Vanderpoll

Role: CONTACT

mvanderpoll@angiodynamics.com

+44 7790921819

Facility Contacts

Ajith Siriwardena, MD FRCS

Role: primary

ajith.siriwardena@mft.nhs.uk

+44

Other Identifiers

2025-ONC-01

Identifier Type: -

Identifier Source: org_study_id