Evaluation of the Ablation of Hepatic Lesions by Electroporation

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Service d'imagerie diagnostique et interventionnelle tri-site des HUPSSD
RECRUITING
Bobigny
Contact Information
Primary
Olivier SUTTER, Pr,MD, PhD
olivier.sutter@aphp.fr
01 72 40 00 12
Backup
Clair POIGNARD, Pr,MD, PhD
clair.poignard@inria.fr
05 40 00 21 27
Time Frame
Start Date: 2023-11-23
Estimated Completion Date: 2025-05-23
Participants
Target number of participants: 50
Related Therapeutic Areas
Sponsors
Collaborators: Inria Team MONC
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov