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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2022-07-29

Brief Summary

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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.

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Detailed Description

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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

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental Arm

Hepatocellular tumours

Group Type EXPERIMENTAL

Interact Active Tracker

Intervention Type RADIATION

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

Interventions

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Interact Active Tracker

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No