Evaluation of Performance of Automatic Fusion for Radiofrequency Ablation of Hepatocellular Carcinoma

Study Overview
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Brief Summary
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Fusion imaging of US and MRI is very helpful for interventional procedure such as radiofrequency ablation in liver. However, manual registration of US and magnetic resonance (MR) imaging is somewhat time-consuming and difficult for less-experienced physicians. Recently, automatic registration function was developed to help the fusion of US and CT/MRI imaging. The purpose of this trial is to compare the registration time and accuracy of manual registration system and automatic registration system.

Detailed Description
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Patients will be randomized and assigned. For automatic registration group, automatic image fusion will be done by RS80A US unit and RF ablation will be performed. Image fusion time will be measured. For manual registration group, manual image fusion will be done by LOGIQ-E9 US unit and RF ablation will be performed. Image fusion time will be measured. 3) After radiofrequency (RF) ablation, immediate, contrast enhanced CT will be performed to evaluate technical success and complications 4) Accuracy of registration will be measured by home-made software using 3D techniques. 5) After one month, technical effectiveness will be evaluated by contrast enhanced CT 6) F/U of CT images will be obtained until one year after RF ablation with a interval of 1-3 months.

Official Title
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Evaluation of Performance of S-fusion for Radiofrequency Ablation of Hepatocellular Carcinoma: A Randomized, Prospective Study

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Device: Automatic Imaging fusion of ultrasonography and MRI
* Device: Manual Imaging fusion of ultrasonography and MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 40-years old Patients with hepatic malignancy who will underwent radiofrequency ablation Exclusion Criteria: Not using fusion imaging (CT guidance or fluoroscopic guidance)

Ages Eligible for Study
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Minimum Age: 40 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automatic registration arm<br>Automatic registration for fusion imaging of US and MRI will be performed. Automatic Imaging fusion of ultrasonography and MRI | Device: Automatic Imaging fusion of ultrasonography and MRI<br>* Radiofrequency ablation for hepatic malignancies will be performed with automatic registration registration. Except the imaging registration, all other procedures for RF ablation is same.<br>|
| Active Comparator: Manual registration arm<br>Manual registration for fusion imaging of US and MRI will be performed. Manual Imaging fusion of ultrasonography and MRI | Device: Manual Imaging fusion of ultrasonography and MRI<br>* Radiofrequency ablation for hepatic malignancies will be performed with manual registration registration. Except the imaging registration, all other procedures for RF ablation is same.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Registration accuracy | Accuracy of imaging fusion (US and MRI) | Immediately after RF ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Completeness of tumor ablation | Within 48 hours after RF ablation | 
| Technical effectiveness | Completeness of tumor ablation | One month after RF ablation | 
| Registration time | Time required for registration | Within 48 hours after RF ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiofrequency ablation, image fusion