Evaluating the use of electroporation to treat liver cancer lesions
Evaluation of the Ablation of Hepatic Lesions by Electroporation
This study is testing a new way to treat hard-to-reach liver cancer tumors using a technique called electroporation to see if it can safely destroy cancer cells without harming nearby healthy tissue.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Bobigny) |
| Trial ID | NCT06289712 on ClinicalTrials.gov |
What this trial studies
This project focuses on the use of irreversible electroporation (IRE) as a treatment for malignant liver tumors that cannot be surgically removed. The EVALHEP project aims to establish criteria for assessing the effectiveness of IRE through imaging techniques and mathematical modeling. By utilizing advanced imaging guidance, interventional radiologists will perform IRE on deep-seated tumors, aiming to destroy cancerous cells while preserving surrounding tissues. The study seeks to address the complexities and variabilities associated with this procedure to improve its clinical application.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a confirmed diagnosis of malignant liver tumors that are not amenable to surgical resection.
Not a fit: Patients with liver tumors that are easily resectable or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safe and effective treatment option for patients with inoperable liver tumors.
How similar studies have performed: While IRE has shown clinical efficacy in previous applications, this study aims to refine its use and assess its effectiveness systematically, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age. * Informed patients who have not objected to participating in the research, or in the case of deceased patients, who have not objected to the processing of their data during their lifetime. * Diagnosis of malignant liver tumor based on either : * Anatomopathological analysis based on an image-guided biopsy prior to surgery (or performed during surgery and contributing to the diagnosis). * Criteria for non-invasive diagnosis of HCC on pre-procedural imaging: CT and/or MRI with contrast injection demonstrating tumor enhancement kinetics after injection typical of HCC (arterial contrast and portal and/or late lavage of a tumor over 10 mm in the presence of chronic liver disease, EASL criteria) and/or Li-RADS 5 classification. * Percutaneous removal of liver tumor by Irreversible Electroporation (IRE) performed during the study period. * Complete peri-interventional imaging file including: * CT and/or MRI of the liver with contrast injection performed within 3 months prior to the procedure * Early liver MRI within 4 days of procedure * Post-treatment hepatic MRI performed 3 to 6 weeks after the IRE procedure * Cone-Beam CT (CBCT) volume reconstructions acquired during the IRE procedure available and including at least : * An initial acquisition before electrode placement * An acquisition with the electrodes in place in their final position * Per-procedural data recorded in the available IRE generator, including the number of electrodes, their schematic spatial configuration, pulse data with test pulses, applied potential (Volt) and measured currents (Amperes) between each electrode combination. Exclusion Criteria: * Contraindications to MRI: * Implantable cardiac pacemaker or defibrillator not compatible with MRI, neurostimulator, cochlear implant, intra-cerebral ferromagnetic vascular clips, intraocular or cerebral metallic foreign bodies, insulin pump * Contraindication to percutaneous IRE treatment due to : * the presence of uncontrolled cardiac rhythm disorders * Presence of a Pacemaker or implantable cardioverter defibrillator * Absence of CBCT volume images of the IRE needles in their final position (or modification of their position between the time of CBCT acquisition and delivery of the electrical impulses). * If the tumor treated corresponds to a remnant after another locoregional treatment modality (but inclusion possible if the tumor treated corresponds to a local recurrence if it was discovered more than 4 months after a locoregional treatment deemed complete). * Patient under guardianship
Where this trial is running
Bobigny
- Service d'imagerie diagnostique et interventionnelle tri-site des HUPSSD — Bobigny, France (Recruiting)
Study contacts
- Study coordinator: Olivier SUTTER, Pr,MD, PhD
- Email: olivier.sutter@aphp.fr
- Phone: 01 72 40 00 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.