CT/MR-US Automatic Fusion System in Pre-procedure Planning for Radiofrequency Ablation

Study Overview
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Brief Summary
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To prospectively evaluate the technical success rate of real-time computed tomography/CT/magnetic resonance imagingMR and -ultrasound (CT/MRI-US) automatic fusion system and the long-term therapeutic efficacy of radiofrequency ablation (RFA) guided by automatic fusion in hepatocellular carcinoma (HCC) patients.

Detailed Description
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RFA is one of commonly used local therapies for primary or secondary liver tumors. For successful and safe procedure, safe route of electrode and lesion visibility are essential for RFA, and the conditions are usually evaluated on pre-RFA planning ultrasonography (USG). However, RFA is sometimes aborted due to limited sonic window of various cause and challenging identification of small isoechoic tumors or hepatocellular carcinomas among dysplastic nodules . Therefore, precise targeting and assuring safe route would be of clinical importance. In this preliminary study, investigators attempted to determine automatic US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors.

Official Title
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Assessment of the Real-time CT/MR-US Automatic Fusion System Using Vascular Matching in Pre-procedure Planning for Radiofrequency Ablation: Preliminary Study

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: automatic CT/MRI-US fusion system guided radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologic or typical imaging based diagnosis of HCC Multiphase CT or MRI within 3 months ahead of procedure No evidence of distant metastasis No contraindications for conventional RFA procedure in our institute, which are uncontrolled coagulopathy (international standard ratio ≥ 1.6, or platelet > 50,000), poor cooperation, unfeasible for sedation, portal vein tumor thrombus, tumor number >4, largest tumor size > 5cm, and tumors abutting portal vein or bile ducts bigger than segmental branches. Exclusion Criteria: Lack of multiphase CT or MRI withing 3 months ahead of procedure RFA planned for palliative purpose Diagnosed as non-HCC malignancy Right hepatectomy state

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>patients undergo routine conventional feasibility planning ultrasound, and clinical decision of RFA feasibility is made based on conventional planning ultrasound. Then additional planning ultrasound using automatic CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging. | Procedure: automatic CT/MRI-US fusion system guided radiofrequency ablation<br>* automatic CT/MRI-US fusion system guided radiofrequency ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate of the fusion process | Absolute technical success rate of the fusion process | Immediately after fusion process | 
| Technical success rate of the overall RFA procedure | Absolute technical success rate of the overall RFA compared to literature | immediately after RFA procedure | 
| Rate of complete ablation of the tumor after 1 month clinical follow up | Rate of complete ablation of the tumor after 1 month clinical follow up compared to literature | 1 month after the RFA procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumor progression rate | Local tumor progression rate after follow up compared to literature | During post procedural follow up to 5 years | 
| Tumor visibility before and after the fusion process | Tumor visibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process. | 10 minutes after finishing planning USG | 
| Technical feasibility before and after the fusion process | Technical feasibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process. | 10 minutes after finishing planning USG | 
| Safety of the approach route before and after the fusion process | Safety of the approach route recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process. | 10 minutes after finishing planning USG | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiofrequency ablation, Fusion imaging