Clinical trial · Observational
Evaluation of the Ablation of Hepatic Lesions by Electroporation
NCT06289712CI-TRIAL-00074637EVALHEPunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Irreversible electroporation is a curative treatment for cancerous liver lesions, performed on deep-seated tumors that are not eligible for surgical resection or percutaneous thermal ablation. The EVALHEP project aims to develop criteria for evaluating the effectiveness of the treatment based on imaging, mathematical models, and numerical simulations to assist radiologists who perform these complex procedures.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Correlate 3D numerical simulations of the IRE electric field with patient imaging follow-up
- timeFrame
- 72 hours and 1 month after treatment
- description
- Demonstrate a correlation between the treatment zones segmented on post-therapy MRI scans and the three-dimensional electric field isolines obtained using digital simulations.
Secondary outcomes (5)
- measure
- Calculation of the tumor coverage rate by the various electric field isolines at different relevant values (for example, three-dimensional isolines between 300 and 700V.cm-1 will be simulated numerically).
- timeFrame
- 72 hours and 1 month after treatment
- description
- Determine a threshold for IRE of liver tumors by combining numerical electric field resolution and post-treatment imaging data.
- measure
- Correlation of recovery rate with treatment outcome and local recurrence during clinical follow-up
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.