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

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Hepatocellular Carcinoma

Treatments

Radiation: Interact Active Tracker

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04420026

2019-A02524-53 (Registry Identifier)

APHP190581

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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