Evaluation of the Ablation of Hepatic Lesions by Electroporation

NCT06289712 | Recruiting

• 1 other identifier: APHP231660
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cancer

Keywords

Liver cancer; Hepatocellular Carcinoma; Irreversible Electroporation

Outcome Measures

Primary Outcomes (1)

• Correlate 3D numerical simulations of the IRE electric field with patient imaging follow-up

  Demonstrate a correlation between the treatment zones segmented on post-therapy MRI scans and the three-dimensional electric field isolines obtained using digital simulations.

  72 hours and 1 month after treatment

Secondary Outcomes (5)

• 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).

  72 hours and 1 month after treatment

• Correlation of recovery rate with treatment outcome and local recurrence during clinical follow-up

  72 hours and 1 month after treatment

• Identification and assessment of imaging biomarkers (radiomics-based) using numerical simulation and post-therapeutic imaging for treatment response evaluation.

  72 hours and 1 month after treatment

• Digital resolution of electrical potential and tissue conductivity values from test pulses at the start of the procedure.

  72 hours and 1 month after treatment

• Develop software solutions potentially usable in real-time and tailored for clinical use.

  72 hours and 1 month after treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with liver cancer (hepatocellular carcinoma) treated by IRE between 2022 and 2023

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Patient under guardianship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Inria Team MONC: collaborator

Study Sites (1)

Service d'imagerie diagnostique et interventionnelle tri-site des HUPSSD

Bobigny, 93009, France

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Olivier SUTTER, Pr,MD, PhD

  Assistance Publique de Paris

  STUDY DIRECTOR

Central Study Contacts

Olivier SUTTER, Pr,MD, PhD

CONTACT

01 72 40 00 12; olivier.sutter@aphp.fr

Clair POIGNARD, Pr,MD, PhD

CONTACT

05 40 00 21 27; clair.poignard@inria.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 4, 2024
• Study Start: November 23, 2023
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)