Hepatocellular CarcinomaIATNCT04420026
Study of Automatic Image Fusion of a CT Volume With Ultrasound During Percutaneous Ablation Treatment of Hepatic Tumors
A study testing Interact Active Tracker in people with Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The automatic fusion of the ultrasound with a cone-beam CT volume will guide the positioning of the electrodes, despite the visibility of the tumor in ultrasound, in patients treated with irreversible electroporation in the interventional radiology room at Avicenna Hospital for hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Interact Active Tracker
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2020to 29 Jul 2022
- Phase
- Interventional
- 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
Who may be able to join
- Age >18 years
- Patient treated at Avicenna Hospital for HCC by irreversible electroporation (IRE)
- Patient whose tumor treatment requires the use of fusion tools with CBCT imaging at the beginning of the procedure
- Patients with a scheduled follow-up examination 1 month after the ablation procedure by irreversible electroporation (IRE)
- Patient who has understood the information and agreed to participate in this research by signing the consent form
- Patient affiliated to a social security system or entitled person
Who cannot join
- Patients with a history of allergy to iodinated contrast material
- Patients with MRI contraindications
- Patients with a history of allergy to contrast material containing gadolinium
- Pregnant or breastfeeding women
- Patients under the protection of justice
- Patients unable to understand research information in an informed manner
- Participation in another interventional therapeutic trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Contribution of Automatic Image Fusion of a Cone-beam CT Volume With Ultrasound During Percutaneous Ablation Treatment of Hepatic Tumors
The automatic fusion of the ultrasound with a cone-beam CT volume will guide the positioning of the electrodes, despite the visibility of the tumor in ultrasound, in patients treated with irreversible electroporation in the interventional radiology room at Avicenna Hospital for hepatocellular carcinoma (HCC). The objective is to evaluate the primary success rate of the automatic cone-beam CT fusion procedure and ultrasound, regardless of the tumor's visibility status in ultrasound.
Read the detailed description
Percutaneous removal of hepatic tumours allows curative treatment using a range of techniques such as radiofrequency ablation, microwave, cryoablation or, more recently, irreversible electroporation. These treatments require the introduction of one or more electrodes into or around the areas to be treated. This insertion phase requires that the practitioner has a means of continuously visualizing the area to be treated and the position of the electrodes.
The reference modality for the treatment of hepatic tumours by ablation is ultrasound. The scanner is the conventional alternative recommended in case of invisibility of the target in ultrasound.
When the target is not clearly visible in ultrasound, advanced multimodal image fusion applications can allow the practitioner to overcome this difficulty. This fusion is made possible by tracking the movement of the ultrasound probe in relation to the patient using an electromagnetic navigation system, and by alignment between the ultrasound system and the fused volume.
This alignment can be done manually or automatically using a specific marker placed on the patient's skin, called an "Active Tracker".
The "INTERACT Active Tracker" functionality will also simplify the registration process by providing automatic pre-registration.
The purpose of this study is to prospectively evaluate the primary success of patients treated at Avicenna Hospital for HCC by irreversible electroporation using this fusion technique. The hypothesis of the study is that this image fusion makes it possible to improve the location of the lesions to be treated and to allow treatment by percutaneous ablation of lesions that are not very visible under ultrasound alone.
This study will also assess the time and accuracy savings when an automatic fusion solution between ultrasound and cone-beam (CB) CT is used, compared to manual alignment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Interact Active Tracker
- Keywords
- ablation, cone-beam CT volume, ultrasonography
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interact Active TrackerRadiation
Interact Active Tracker, allowing the automation of the fusion between a CBCT and ultrasound imaging
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Hepatocellular tumours Receives: Radiation: Interact Active Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the primary success rate of percutaneous ablation treatment with IRE of hepatic tumors, as a function of the ultrasound visibility of the tumor, when using automatic CT cone-beam fusion and ultrasound
Primary success is assessed on the control MRI or CT performed one month after the first IRE (Irreversible Electroporation) ablation procedure targeting a given tumor. It is defined by the absence of visible recurrence at 1 month on post-operative imaging. In the case of a partial response, a % of active tumor will be evaluated.
Measured: At 1 month on post-operative imaging
Secondary outcomes (10)
Evaluate the time savings when using "INTERACT Active Tracker" allowing automatic alignment of the CBCT volume with ultrasound
The ultrasound visibility of the tumor is evaluated by an ordered discrete variable defined as follows:
0: Not identifiable with or without merging
- identifiable with the help of fusion, tumor boundaries are poorly defined
- identifiable with the help of fusion, the limits of the tumour are clearly visible
- identifiable without fusion, tumor boundaries are poorly defined
- identifiable without fusion, the limits of the tumour are clearly visible
Measured: The day of the operation
Evaluate the time saved by using "INTERACT Active Tracker" allowing automatic alignment of the CBCT volume with ultrasound compared to the manual alignment procedure performed on a series of patients treated when the new function was not available.
Time is measured from the moment the entire volume is loaded onto the ultrasound scanner. The stopwatch is stopped when the operator declares himself satisfied with the adjustment
Measured: The day of the operation
Evaluate the confidence gain associated with the use of ultrasound fusion.
The confidence gain associated with the use of ultrasound fusion is assessed by noting the number of non-visible or non-localizable tumors in ultrasound alone that can be identified through fusion.
Measured: The day of the operation
Evaluate the accuracy of the automatic alignment judged on the ultrasound measurement of the distance from the center of the target seen in ultrasound to that segmented on the pre-therapeutic pour Cone Beam Computed Tomography (CBCT).
The accuracy of the automatic alignment judged on the ultrasound measurement of the distance from the center of the target seen in ultrasound to that segmented on the pre-therapeutic CBCT is evaluated by comparison with the accuracy of the manual alignment recorded on a series of patients treated when the new function was not available
Measured: The day of the operation
Evaluate the percentage of procedures for which similarity points must be added due to an initial delay in automatic merging that the operator considers too long.
The percentage of procedures for which similarity points must be added due to an initial delay of the automatic merge considered too long by the operator is evaluated in comparison with the historical series (manual alignment, when the new function was not available).
Measured: The day of the operation
Evaluate the failure rate of the Interact Active Tracker automatic alignment.
If the operator is not satisfied with the automatic registration between the CBCT and ultrasound, the number of similarity point(s) to be placed and the time required to make this adjustment will be recorded
Measured: The day of the operation
Evaluate the secondary and third-party therapeutic effectiveness rate of the procedures.
The failure rate of the Interact Active Tracker automatic alignment is evaluated by the number of procedures where this function is not functional for any reason. Throughout the procedure, the number of times the operator will have to correct the alignment with new anatomical landmarks will be counted. Any failure of the automatic merge will be recorded.
Measured: The day of the operation
For incomplete responses, estimate the percentage of active tumour (enhanced by contrast material).
The secondary and third-party therapeutic effectiveness rate of the procedures is defined by the number of cases in which two or three ablation procedures will be required to achieve a complete MRI response within one month of the last ablation session. For each tumour, the number of ablation procedures required to achieve a complete MRI response within one month of the last ablation session will be recorded. For patients requiring more than one treatment, only treatments performed over the duration of the study should be included.
Measured: One month after the ablation
Assess the complication rate.
The complication rate is evaluated by the Dindo-Clavian classification so complication will be recorded and classified
Measured: The day of the ablation
Evaluate the global survival at 12 months
Overall survival at 12 months. It will be collected by consulting medical records based on the recorded dates of the last visits, images...
Measured: 12 months after the ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start6 Jul 2020
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Sponsor
- Investigators
- Olivier Mr SEROR, PhD, Principal investigator, Assistance Publique - Hôpitaux Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420026
- Sponsor's protocol ID
- APHP190581
- Other IDs
- 2019-A02524-53
- Acronym
- IAT
- Status last verified
- Sep 2022
- First submitted
- 4 May 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nault JC, Sutter O, Nahon P, Ganne-Carrie N, Seror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13.
PubMed 29031662Yu H, Burke CT. Comparison of percutaneous ablation technologies in the treatment of malignant liver tumors. Semin Intervent Radiol. 2014 Jun;31(2):129-37. doi: 10.1055/s-0034-1373788.
PubMed 25071303Monfardini L, Orsi F, Caserta R, Sallemi C, Della Vigna P, Bonomo G, Varano G, Solbiati L, Mauri G. Ultrasound and cone beam CT fusion for liver ablation: technical note. Int J Hyperthermia. 2018;35(1):500-504. doi: 10.1080/02656736.2018.1509237. Epub 2018 Sep 11.
PubMed 30204007Lee LH, Hwang JI, Cheng YC, Wu CY, Lee SW, Yang SS, Yeh HZ, Chang CS, Lee TY. Comparable Outcomes of Ultrasound versus Computed Tomography in the Guidance of Radiofrequency Ablation for Hepatocellular Carcinoma. PLoS One. 2017 Jan 9;12(1):e0169655. doi: 10.1371/journal.pone.0169655. eCollection 2017.
PubMed 28068369Cornelis FH, Korenbaum C, Ben Ammar M, Tavolaro S, Nouri-Neuville M, Lotz JP. Multimodal image-guided electrochemotherapy of unresectable liver metastasis from renal cell cancer. Diagn Interv Imaging. 2019 May;100(5):309-311. doi: 10.1016/j.diii.2019.01.001. Epub 2019 Jan 26. No abstract available.
PubMed 30691970
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Contribution of Automatic Image Fusion of a Cone-beam CT Volume With Ultrasound During Percutaneous Ablation Treatment of Hepatic Tumors
- ClinicalTrials.gov ID
- NCT04420026
- Acronym / sponsor ID
- IAT / APHP190581
- Conditions
- Hepatocellular Carcinoma
- Keywords
- ablation, cone-beam CT volume, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 9 Jun 2020 (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.
The automatic fusion of the ultrasound with a cone-beam CT volume will guide the positioning of the electrodes, despite the visibility of the tumor in ultrasound, in patients treated with irreversible electroporation in the interventional radiology room at Avicenna Hospital for hepatocellular carcinoma (HCC). The objective is to evaluate the primary success rate of the automatic cone-beam CT fusion procedure and ultrasound, regardless of the tumor's visibility status in ultrasound.
Detailed description
Percutaneous removal of hepatic tumours allows curative treatment using a range of techniques such as radiofrequency ablation, microwave, cryoablation or, more recently, irreversible electroporation. These treatments require the introduction of one or more electrodes into or around the areas to be treated. This insertion phase requires that the practitioner has a means of continuously visualizing the area to be treated and the position of the electrodes.
The reference modality for the treatment of hepatic tumours by ablation is ultrasound. The scanner is the conventional alternative recommended in case of invisibility of the target in ultrasound.
When the target is not clearly visible in ultrasound, advanced multimodal image fusion applications can allow the practitioner to overcome this difficulty. This fusion is made possible by tracking the movement of the ultrasound probe in relation to the patient using an electromagnetic navigation system, and by alignment between the ultrasound system and the fused volume.
This alignment can be done manually or automatically using a specific marker placed on the patient's skin, called an "Active Tracker".
The "INTERACT Active Tracker" functionality will also simplify the registration process by providing automatic pre-registration.
The purpose of this study is to prospectively evaluate the primary success of patients treated at Avicenna Hospital for HCC by irreversible electroporation using this fusion technique. The hypothesis of the study is that this image fusion makes it possible to improve the location of the lesions to be treated and to allow treatment by percutaneous ablation of lesions that are not very visible under ultrasound alone.
This study will also assess the time and accuracy savings when an automatic fusion solution between ultrasound and cone-beam (CB) CT is used, compared to manual alignment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Radiation: Interact Active TrackerHepatocellular tumours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years
- Patient treated at Avicenna Hospital for HCC by irreversible electroporation (IRE)
- Patient whose tumor treatment requires the use of fusion tools with CBCT imaging at the beginning of the procedure
- Patients with a scheduled follow-up examination 1 month after the ablation procedure by irreversible electroporation (IRE)
- Patient who has understood the information and agreed to participate in this research by signing the consent form
Key exclusion criteria (7 listed)
- Patients with a history of allergy to iodinated contrast material
- Patients with MRI contraindications
- Patients with a history of allergy to contrast material containing gadolinium
- Pregnant or breastfeeding women
- Patients under the protection of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interact Active TrackerInteract Active Tracker, allowing the automation of the fusion between a CBCT and ultrasound imaging | Radiation | Experimental Arm |
Primary outcome
Evaluation of the primary success rate of percutaneous ablation treatment with IRE of hepatic tumors, as a function of the ultrasound visibility of the tumor, when using automatic CT cone-beam fusion and ultrasound
Time frame: At 1 month on post-operative imaging
Primary success is assessed on the control MRI or CT performed one month after the first IRE (Irreversible Electroporation) ablation procedure targeting a given tumor. It is defined by the absence of visible recurrence at 1 month on post-operative imaging. In the case of a partial response, a % of active tumor will be evaluated.
10 secondary outcomes
Evaluate the time savings when using "INTERACT Active Tracker" allowing automatic alignment of the CBCT volume with ultrasound
Time frame: The day of the operation
Evaluate the time saved by using "INTERACT Active Tracker" allowing automatic alignment of the CBCT volume with ultrasound compared to the manual alignment procedure performed on a series of patients treated when the new function was not available.
Time frame: The day of the operation
Evaluate the confidence gain associated with the use of ultrasound fusion.
Time frame: The day of the operation
Evaluate the accuracy of the automatic alignment judged on the ultrasound measurement of the distance from the center of the target seen in ultrasound to that segmented on the pre-therapeutic pour Cone Beam Computed Tomography (CBCT).
Time frame: The day of the operation
Evaluate the percentage of procedures for which similarity points must be added due to an initial delay in automatic merging that the operator considers too long.
Time frame: The day of the operation
Evaluate the failure rate of the Interact Active Tracker automatic alignment.
Time frame: The day of the operation
Evaluate the secondary and third-party therapeutic effectiveness rate of the procedures.
Time frame: The day of the operation
For incomplete responses, estimate the percentage of active tumour (enhanced by contrast material).
Time frame: One month after the ablation
Assess the complication rate.
Time frame: The day of the ablation
Evaluate the global survival at 12 months
Time frame: 12 months after the ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Background: PubMed 29031662Nault JC, Sutter O, Nahon P, Ganne-Carrie N, Seror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13.
- Background: PubMed 25071303Yu H, Burke CT. Comparison of percutaneous ablation technologies in the treatment of malignant liver tumors. Semin Intervent Radiol. 2014 Jun;31(2):129-37. doi: 10.1055/s-0034-1373788.
- Background: PubMed 30204007Monfardini L, Orsi F, Caserta R, Sallemi C, Della Vigna P, Bonomo G, Varano G, Solbiati L, Mauri G. Ultrasound and cone beam CT fusion for liver ablation: technical note. Int J Hyperthermia. 2018;35(1):500-504. doi: 10.1080/02656736.2018.1509237. Epub 2018 Sep 11.
- Background: PubMed 28068369Lee LH, Hwang JI, Cheng YC, Wu CY, Lee SW, Yang SS, Yeh HZ, Chang CS, Lee TY. Comparable Outcomes of Ultrasound versus Computed Tomography in the Guidance of Radiofrequency Ablation for Hepatocellular Carcinoma. PLoS One. 2017 Jan 9;12(1):e0169655. doi: 10.1371/journal.pone.0169655. eCollection 2017.
- Background: PubMed 30691970Cornelis FH, Korenbaum C, Ben Ammar M, Tavolaro S, Nouri-Neuville M, Lotz JP. Multimodal image-guided electrochemotherapy of unresectable liver metastasis from renal cell cancer. Diagn Interv Imaging. 2019 May;100(5):309-311. doi: 10.1016/j.diii.2019.01.001. Epub 2019 Jan 26. No abstract available.
- Minimally Invasive Treatments for Liver Cancer, Updates in Liver Cancer. Nicolas Cardenas, Rahul Sheth and Joshua Kuban.Link provided by the sponsor.
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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 Mr SEROR, PhD principal investigator
Assistance Publique - Hôpitaux Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interact Active Tracker in people with Hepatocellular Carcinoma, 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 4 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the primary success rate of percutaneous ablation treatment with IRE of hepatic tumors, as a function of the ultrasound visibility of the tumor, when using automatic CT cone-beam fusion and ultrasound (time frame: At 1 month on post-operative imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04420026, which also lists 5 linked publications.
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 Oct 2022.