Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using CT or MR/US Fusing Imaging

Study Overview
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Brief Summary
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The purpose of this study is to determine whether fusion technique of preradiofrequency ablation (RFA) or percutaneous liver biopsy cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA or liver biopsy in patients with liver tumor in comparison with ultrasonography guidance alone. And assessment of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).

Detailed Description
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RFA is one of commonly used local therapies for primary or secondary liver tumors. And percutaneous liver biopsy is very important technique to confirm the diagnosis of focal hepatic lesion whether benign or malignancy. For successful and safe procedure, safe access route and lesion visibility are essential , and the conditions are usually evaluated on pre-procedure planning ultrasonography (USG). However, these procedure 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 or liver biopsy feasibility in patients with liver tumors in comparison with conventional US alone technique. In addition, to assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).

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

Conditions
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Liver Mass, Liver Fibroses

Intervention / Treatment
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* Device: CT/US fusion
* Device: ultrasound shear wave elastography


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 or percutaneous liver biopsy available pre-procedure liver CT or liver MR imaging within 6 weeks Exclusion Criteria: any contraindication of liver RFA or percutaneous liver biopsy • any patients who received treatment between pre-RFA imaging and planned RFA.

Ages Eligible for Study
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Minimum Age: 20 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: CT/US fusion<br>patients undergo routine conventional feasibility planning ultrasound, and clinical decision of percutaneous liver biopsy or 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-procedure cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.<br>Device: ultrasound shear wave elastography<br>* ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.<br>* Other names: S-shear wave;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RFA or biopsy 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 | 
| Assessment of a new point shear-wave elastography method (pSWE, S-shear wave) | To assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI). | 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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Fusion, Ablation, Percutaneous biopsy, Shear wave elastography