NCT07191548Not yet recruiting
International Study on Treatment of Patients With Metastatic Colorectal Liver Lesions Patients With IRE
Treatment of LIVER METastases From Colorectal Cancer by IRreversible Electroporation: A Prospective, International, Multi-centre Cohort Study.
Source: ClinicalTrials.gov · Last updated 10 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 23 Sept 2025
- Start date
- Feb 2026
- Primary completion date
- Feb 2028
- Lead sponsor
- Angiodynamics, Inc.
- NCT number
- NCT07191548
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Feb 2026 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior hepatic tumour ablation.
- Cardiovascular fitness related exclusions:
Other illness
- History of ventricular arrhythmia.
- Congestive cardiac failure NYHA Class ≥ 3.
- Tumour-related exclusions:
- Advanced multi-site metastatic cancer (any of the following): peritoneal metastases (M1c), bone metastases, \> 2 lung metastases, all segment involvement multiple liver metastases.
Lab values
- Platelet count \< 50x109 U/L.
- International normalised ratio (INR) for blood clotting \> 1.7.
- Jaundice (serum bilirubin \> 30 µmol/L).
Other
- Patients involved in other research studies.
- Inability to give informed consent.
- Patients who are pregnant.
- Accepted exclusions to IRE from consensus criteria including:
- Implanted pacemaker or defibrillator.
- Tumour ≥ 4 cm in size.
- MDT/tumour recommends use of thermal ablation instead of IRE for any given lesion.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Manchester Royal Infirmiary Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.