Clinical trial NCT04420026: Study of Automatic Image Fusion of a CT Volume With Ultrasound During Percutaneous Ablation Treatment of Hepatic Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: ablation
cone-beam CT volume
ultrasonography
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2020-06-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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
timeFrame: At 1 month on post-operative imaging
Secondary outcomes:
measure: Evaluate the time savings when using "INTERACT Active Tracker" allowing automatic alignment of the CBCT volume with ultrasound
timeFrame: The day of the operation
measure: 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.
timeFrame: The day of the operation
measure: Evaluate the confidence gain associated with the use of ultrasound fusion.
timeFrame: The day of the operation
measure: 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).
timeFrame: The day of the operation
measure: 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.
timeFrame: The day of the operation
measure: Evaluate the failure rate of the Interact Active Tracker automatic alignment.
timeFrame: The day of the operation
measure: Evaluate the secondary and third-party therapeutic effectiveness rate of the procedures.
timeFrame: The day of the operation
measure: For incomplete responses, estimate the percentage of active tumour (enhanced by contrast material).
timeFrame: One month after the ablation
measure: Assess the complication rate.
timeFrame: The day of the ablation
measure: Evaluate the global survival at 12 months
timeFrame: 12 months after the ablation
Other outcomes:
Locations:
city: Bobigny
country: France
facility: SERROR
Study officials:
affiliation: Assistance Publique - Hôpitaux Paris
name: Olivier Mr SEROR, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Yu 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.
citation: Monfardini 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.
citation: Lee 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.
citation: Cornelis 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.