Evaluation of the Ablation of Hepatic Lesions by Electroporation (NCT06289712) | Clinical Trial Compass
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Evaluation of the Ablation of Hepatic Lesions by Electroporation
France50 participantsStarted 2023-11-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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, includin…
What they're measuring
1
Correlate 3D numerical simulations of the IRE electric field with patient imaging follow-up