Study of Automatic Image Fusion of a CT Volume With Ultrasound During Percutaneous Ablation Treatment of Hepatic Tumors

N/ACompletedNCT04420026

Assistance Publique - Hôpitaux de Paris44 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Conditions

Hepatocellular Carcinoma

Interventions

Interact Active TrackerRADIATION

Interact Active Tracker, allowing the automation of the fusion between a CBCT and ultrasound imaging

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

SERROR

Bobigny, France

Outcomes

Primary Outcomes

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.

Time frame: At 1 month on post-operative imaging

Secondary Outcomes

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 1. identifiable with the help of fusion, tumor boundaries are poorly defined 2. identifiable with the help of fusion, the limits of the tumour are clearly visible 3. identifiable without fusion, tumor boundaries are poorly defined 4. identifiable without fusion, the limits of the tumour are clearly visible

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 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

Time frame: 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.

Data from ClinicalTrials.gov

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