Pre-procedure Planning for Radiofrequency Ablation Using CT or MR/US Fusion

Study Overview
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Brief Summary
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The purpose of this study is to determine whether fusion technique of pre-radiofrequency ablation (RFA) cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA in patients with liver tumor in comparison with ultrasonography guidance alone.

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 US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors in comparison with conventional US alone technique.

Official Title
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Pre-procedure Planning for Radiofrequency Ablation Using the Automatic Fusion Images of the Registrated 3D CT or MR-US Scans: Preliminary Study

Conditions
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Liver Cancer

Intervention / Treatment
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* Device: CT/US fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all conditions should be satisfied for inclusion. referred to Radiology in our institution for liver tumor RFA available pre-RFA liver CT or liver MR imaging within 6 weeks Exclusion Criteria: patients with any of following condition should be excluded. any contraindication of liver RFA any patients who received treatment between pre-RFA imaging and planned RFA patients referred for palliative purpose.
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 |
| --- | --- |
| Other: CT/US fusion<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 CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging. | Device: CT/US fusion<br>* Fusion of pre-RFA cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RFA feasibility rates on planning USG with/without fusion CT/MR and US | comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG | 10 minutes after finishing planning USG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of tumor visibility on planning USG with/without fusion technique | comparison of tumor visibility (or detection) rates on planning USG on conventional planning USG and fusion planning USG | 10 minutes after finishing planning USG | 
| Number of patients with safety access route on planning USG with/without fusion technique | comparison of number of patients with presence/absence of safety access route, and the on two planning USGs | 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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ablation, fusion