Safety Margin Assessment After RFA Using the Registration of Pre-ablation MRI and Post-ablation CT

Study Overview
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Brief Summary
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Magnetic resonance imaging (MRI) has been widely used for small liver lesion detection and characterization. In patients who undergo RFA, MRI is often performed before RFA, whereas immediate technical success is usually assessed by CT. Conventional visual assessment of two modalities may be more challenging than being anticipated, because acquisition position, respiration, and spatial resolution differ between the two. Therefore, the study purpose is to evaluate the results of software-assisted ablative margin assessment using registration of different pre-and post-RFA modalities compared with the conventional method of side-by-side MRI-CT comparison in patients with HCCs.

Official Title
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Prospective Evaluation of Local Tumor Progression After Radiofrequency Ablation of Hepatocellular Carcinoma: Effectiveness of Immediate Second-Look Evaluation Using Pre-RFA MRI and Post-RFA CT Registration

Conditions
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HCC, Liver Tumor

Intervention / Treatment
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* Procedure: RFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients (≥ 18 years) who were referred to our radiology department for liver tumor RFA patients who had liver MR images of sufficient quality for pre-RFA evaluation within 30 days before RFA patients with 1-3 tumors (<5 cm) Exclusion Criteria: Child-Pugh class C any uncorrected coagulopathy hypersensitivity to iodine or other reasons that prevented the performance of post-RFA contrast-enhanced CT

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: RFA|Radiofrequency ablation (RFA) is performed according to routine practice, and then safety margin is assessed by a) visual side-by-side comparison between pre-RFA MRI and post-RFA CT, and b) registration software for two modalities.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumor progression (LTP) | 5-year-LTP rate in HCC between sufficient and insufficient ablative margin groups (according to visual assessment and registration software-assisted assessment) | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technique efficacy | Rate of absence of viable tumor on 1-months follow-up CT scan. | 1 month after RFA | 
| immediate technical success on visual assessment | technical success of RFA on post-RFA CT using side-by-side comparison of pre-RFA MRI and post-RFA CT | 1 day after RFA | 
| immediate technical success on registration-software assessment | technical success of RFA on post-RFA CT using registration-software assessment between pre-RFA MRI and post-RFA CT | 1 day after RFA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, RFA, Liver tumor