---
title: International Study on Treatment of Patients With Metastatic Colorectal Liver Lesions Patients With IRE
nct_id: NCT07191548
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: Angiodynamics, Inc.
study_type: INTERVENTIONAL
primary_condition: Colorectal Adenocarcinoma Metastatic in the Liver
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07191548.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07191548"
ct_last_update_post_date: 2025-10-10
last_seen_at: "2026-05-12T07:32:22.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# International Study on Treatment of Patients With Metastatic Colorectal Liver Lesions Patients With IRE

**Official Title:** Treatment of LIVER METastases From Colorectal Cancer by IRreversible Electroporation: A Prospective, International, Multi-centre Cohort Study.

**NCT ID:** [NCT07191548](https://clinicaltrials.gov/study/NCT07191548)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Angiodynamics, Inc.
- **Conditions:** Colorectal Adenocarcinoma Metastatic in the Liver, Liver Ablation, Liver Cancer, Adult
- **Start Date:** 2026-02
- **Completion Date:** 2029-02
- **CT.gov Last Update:** 2025-10-10

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Use of NanoKnife System for ablation of metastatic colorectal lesions** (EXPERIMENTAL)

## 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.

## Primary Outcomes

- **Target Tumour Eradication** _(time frame: 6 months)_ — The percentage of target tumours successfully eradicated 6 months after the initial IRE procedure, according to RECIST and PERCIST criteria.

## Secondary Outcomes

- **Complications of IRE: Episode-related complications:** _(time frame: 30 days)_
- **Complications of IRE: Intervention for local liver-related complications of IRE** _(time frame: 12 months)_
- **Oncological outcomes: Local progression at site of IRE-treated lesion** _(time frame: 12 months)_
- **Oncological Outcomes: Re-ablation and modality.** _(time frame: 12 months)_
- **Oncological Outcomes: New lesions** _(time frame: 12 months)_
- **Oncological Outcomes: Post IRE Chemotherapy** _(time frame: 12 months)_
- **Oncological Outcomes: Other liver-directed interventions** _(time frame: 12 months)_
- **Oncological Outcomes: Disease-free and overall survival from time of IRE.** _(time frame: 12 months)_
- **Quality of life - pre procedure** _(time frame: pre procedure up to 7 days)_
- **Quality of life - 7 days follow-up** _(time frame: 7 days)_
- **Quality of life - 6 months** _(time frame: 6 months)_

## Locations (1)

- Manchester Royal Infirmiary, Manchester, United Kingdom

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.manchester royal infirmiary|manchester||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07191548.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07191548*  
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