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

NCT07191548 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2025-ONC-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

irreversible electroporation; liver ablation; metastatic liver disease; nanoknife; liver ire registry

Outcome Measures

Primary Outcomes (1)

• Target Tumour Eradication

  The percentage of target tumours successfully eradicated 6 months after the initial IRE procedure, according to RECIST and PERCIST criteria.

  6 months

Secondary Outcomes (11)

• Complications of IRE: Episode-related complications:

  30 days

• Complications of IRE: Intervention for local liver-related complications of IRE

  12 months

• Oncological outcomes: Local progression at site of IRE-treated lesion

  12 months

• Oncological Outcomes: Re-ablation and modality.

  12 months

• Oncological Outcomes: New lesions

  12 months

Study Arms (1)

Use of NanoKnife System for ablation of metastatic colorectal lesions

EXPERIMENTAL

Device: Irreversible Electroporation

Interventions

Irreversible Electroporation 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.

Also known as: nanoknife

Use of NanoKnife System for ablation of metastatic colorectal lesions

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 years and over, able to provide informed consent and with histological confirmation of a diagnosis of colorectal cancer from primary tumour.
• 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

You may not qualify if:

• Patients involved in other research studies.
• Inability to give informed consent.
• Patients who are pregnant.
• Platelet count \< 50x109 U/L.
• International normalised ratio (INR) for blood clotting \> 1.7.
• Prior hepatic tumour ablation.
• History of ventricular arrhythmia.
• Implanted pacemaker or defibrillator.
• Congestive cardiac failure NYHA Class ≥ 3.
• 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.

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

Study Sites (1)

Manchester Royal Infirmiary

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Diseases

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ajith Siriwardena, MD FRCS

  Manchester Royal Infirmiary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitchell Vanderpoll

CONTACT

+44 7790921819; mvanderpoll@angiodynamics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an international, prospective, multi-centre, registry-based, non-randomized, single arm, clinical cohort study of the use of IRE for the treatment of liver metastases from colorectal cancer in patients who have received systemic chemotherapy.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: September 25, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

GB (1)