Liver CancerEVALHEPNCT06289712
Evaluation of the Ablation of Hepatic Lesions by Electroporation
An observational study of Liver Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2023to 23 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver cancer (hepatocellular carcinoma) treated by IRE between 2022 and 2023
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'imagerie diagnostique et interventionnelle tri-site des HUPSSD
Bobigny, 93009
Olivier SUTTER, 01 72 40 00 12, olivier.sutter@aphp.fr
About this study
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.
Read the detailed description
Percutaneous destruction of malignant liver tumors has been developing in routine clinical practice for around twenty years, and is performed by interventional radiologists under imaging guidance (ultrasound, computed tomography (CT), Cone-Beam CT...).
Irreversible electroporation (IRE) is a percutaneous tumor destruction technique distinguished from other ablation methods by its non-thermal mechanism of action. The rationale behind IRE is that cells subjected to a powerful pulsed electric field will have their membrane irreversibly damaged and destroyed, while the surrounding extracellular matrix will be respected. This technology offers the opportunity to effectively destroy lesions that would be impossible to treat by any other method, due to their critical tumor location, close to vital structures at risk.
Although it has demonstrated its clinical efficacy over the years, with the potential to provide safe, curative treatment for patients with deep, poorly located tumors, IRE is considered a complex procedure, subject to numerous variability factors, and remains under-utilized to this day. Precise insertion of several needles (up to 6) at tumor level is required to obtain a homogeneous electric field of sufficient intensity. To date, there is no way of assessing the effectiveness of the procedure in real time, and inaccuracies in needle positioning or in treatment parameters will generate changes in the distribution of the electric field that may adversely affect treatment efficacy. What's more, it remains difficult to assess treatment efficacy on post-therapy images, the interpretation of which is subject to controversy.
The Interventional Radiology (IR) unit of the University Hospitals of Paris Seine Saint Denis (HUPSSD) has been using IRE for over 10 years as part of its clinical routine, mainly for the ablation of liver tumors, and in particular hepatocellular carcinoma (HCC) which is inoperable and ineligible for conventional thermo-ablation. Over the past ten years, more than 350 patients have benefited from one or more IREs for the treatment of liver tumors at HUPSSD, making the department a reference center in the field.
Thanks to the contributions of mathematics applied to oncology, numerical tools and the clinical experience of the HUPSSD IR department, the aim of this project is to develop evaluation criteria for IRE ablations of liver tumors based on clinical imaging and numerical simulations of the electric field.
- Conditions
- Liver Cancer
- Keywords
- Liver cancer, Hepatocellular Carcinoma, Irreversible Electroporation
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Determine a threshold for IRE of liver tumors by combining numerical electric field resolution and post-treatment imaging data.
Measured: 72 hours and 1 month after treatment
Correlation of recovery rate with treatment outcome and local recurrence during clinical follow-up
Assess inter-individual variations in liver and tumor conductivity values based on impedance data provided by the IRE generator.
Measured: 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.
Determine a threshold electric field value to be reached for complete treatment (calculation of sensitivity, specificity, PPV, NPV, ROC curve)
Measured: 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.
Evaluate the most suitable and clinically relevant numerical electroporation model (linear/non-linear, static/dynamic).
Measured: 72 hours and 1 month after treatment
Develop software solutions potentially usable in real-time and tailored for clinical use.
Demonstrate a correlation between the treatment zones segmented on post-therapy MRI
Measured: 72 hours and 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start23 Nov 2023
- Primary completion23 May 2025 (estimated)
- Study completion23 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Inria Team MONC
- Responsible party
- Sponsor
- Investigators
- Olivier SUTTER, Pr,MD, PhD, Study director, Assistance Publique de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289712
- Sponsor's protocol ID
- APHP231660
- Acronym
- EVALHEP
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ablation of Hepatic Lesions by Electroporation
- ClinicalTrials.gov ID
- NCT06289712
- Acronym / sponsor ID
- EVALHEP / APHP231660
- Conditions
- Liver Cancer
- Keywords
- Liver cancer, Hepatocellular Carcinoma, Irreversible Electroporation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Inria Team MONC
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 23 May 2025 (estimated)
- Study completion
- 23 May 2025 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Percutaneous destruction of malignant liver tumors has been developing in routine clinical practice for around twenty years, and is performed by interventional radiologists under imaging guidance (ultrasound, computed tomography (CT), Cone-Beam CT...).
Irreversible electroporation (IRE) is a percutaneous tumor destruction technique distinguished from other ablation methods by its non-thermal mechanism of action. The rationale behind IRE is that cells subjected to a powerful pulsed electric field will have their membrane irreversibly damaged and destroyed, while the surrounding extracellular matrix will be respected. This technology offers the opportunity to effectively destroy lesions that would be impossible to treat by any other method, due to their critical tumor location, close to vital structures at risk.
Although it has demonstrated its clinical efficacy over the years, with the potential to provide safe, curative treatment for patients with deep, poorly located tumors, IRE is considered a complex procedure, subject to numerous variability factors, and remains under-utilized to this day. Precise insertion of several needles (up to 6) at tumor level is required to obtain a homogeneous electric field of sufficient intensity. To date, there is no way of assessing the effectiveness of the procedure in real time, and inaccuracies in needle positioning or in treatment parameters will generate changes in the distribution of the electric field that may adversely affect treatment efficacy. What's more, it remains difficult to assess treatment efficacy on post-therapy images, the interpretation of which is subject to controversy.
The Interventional Radiology (IR) unit of the University Hospitals of Paris Seine Saint Denis (HUPSSD) has been using IRE for over 10 years as part of its clinical routine, mainly for the ablation of liver tumors, and in particular hepatocellular carcinoma (HCC) which is inoperable and ineligible for conventional thermo-ablation. Over the past ten years, more than 350 patients have benefited from one or more IREs for the treatment of liver tumors at HUPSSD, making the department a reference center in the field.
Thanks to the contributions of mathematics applied to oncology, numerical tools and the clinical experience of the HUPSSD IR department, the aim of this project is to develop evaluation criteria for IRE ablations of liver tumors based on clinical imaging and numerical simulations of the electric field.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver cancer (hepatocellular carcinoma) treated by IRE between 2022 and 2023
Key inclusion criteria (14 listed)
- 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 :
- Percutaneous removal of liver tumor by Irreversible Electroporation (IRE) performed during the study period.
- Complete peri-interventional imaging file including:
Key exclusion criteria (8 listed)
- Contraindications to MRI:
- Contraindication to percutaneous IRE treatment due to :
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlate 3D numerical simulations of the IRE electric field with patient imaging follow-up
Time frame: 72 hours and 1 month after treatment
Demonstrate a correlation between the treatment zones segmented on post-therapy MRI scans and the three-dimensional electric field isolines obtained using digital simulations.
5 secondary outcomes
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).
Time frame: 72 hours and 1 month after treatment
Correlation of recovery rate with treatment outcome and local recurrence during clinical follow-up
Time frame: 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.
Time frame: 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.
Time frame: 72 hours and 1 month after treatment
Develop software solutions potentially usable in real-time and tailored for clinical use.
Time frame: 72 hours and 1 month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier SUTTER, Pr,MD, PhD study director
Assistance Publique de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier SUTTER, Pr,MD, PhD (01 72 40 00 12, olivier.sutter@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate 3D numerical simulations of the IRE electric field with patient imaging follow-up (time frame: 72 hours and 1 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.