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Evaluation of the Ablation of Hepatic Lesions by Electroporation
RECRUITINGSponsored by Assistance Publique - Hôpitaux de Paris
Actively Recruiting
SponsorAssistance Publique - Hôpitaux de Paris
Started2023-11-23
Est. completion2025-05-23
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06289712
Summary
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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
Conditions3
CancerLiver CancerLiver Disease
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Actively Recruiting
SponsorAssistance Publique - Hôpitaux de Paris
Started2023-11-23
Est. completion2025-05-23
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06289712