Study of the Contribution of Automatic Image Fusion of a Cone-beam CT Volume With Ultrasound During Percutaneous Ablation Treatment of Hepatic Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: 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.
次要结局
- Evaluate the confidence gain associated with the use of ultrasound fusion.(The day of the operation)
- Evaluate the secondary and third-party therapeutic effectiveness rate of the procedures.(The day of the operation)
- For incomplete responses, estimate the percentage of active tumour (enhanced by contrast material).(One month after the ablation)
- 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.(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 day of the operation)
- Evaluate the failure rate of the Interact Active Tracker automatic alignment.(The day of the operation)
- Evaluate the time savings when using "INTERACT Active Tracker" allowing automatic alignment of the CBCT volume with ultrasound(The day of the operation)
- Evaluate the global survival at 12 months(12 months after the ablation)
- 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 day of the operation)
- Assess the complication rate.(The day of the ablation)