Intraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation

Study Overview
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Brief Summary
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A pre- and postablation scan will be made intraprocedurally to investigate the feasibility of intraprocedural ablation verification assessment using coregistration software

Official Title
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Intraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation

Conditions
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HCC

Intervention / Treatment
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* Diagnostic Test: Additional intraprocedural pre-ablation CT-scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 yrs or above HCC very early (0) or early stage (A) according to the BCLC staging system Either de novo or recurrent HCC (prior locoregional therapy is allowed in the study) Candidate for percutaneous thermal ablation as discussed in a multidisciplinary tumor board. Ablation as 'bridge-to-transplant' is allowed in the study Exclusion Criteria: Estimated GFR <30 ml/min Morbid obesitas or any pulmonary condition that is a contraindication to prolonged apnea and high jet-ventilation Child Pugh C Portal vein tumor invasion Extrahepatic metastasis Uncorrectable coagulopathy Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule Inability or unwillingness to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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
Interventional Model Description: prospective, single blind, single-arm, phase II stud
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Additional intraprocedural CT-scan<br>Additional intraprocedural CT-scan | Diagnostic Test: Additional intraprocedural pre-ablation CT-scan<br>* In 20 patients, besides de regular post-RFA scan, a pre-RFA contrast enhanced dual phase CT-scan will be acquired to investigate the feasibility of quantitative ablation assessment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the use of co-registration software (>80%) | The proportion of patients in whom reliable co-registration of pre- and post-ablation CT images is feasible | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter and intra-observer variability | Inter- and intraobserver variability of CT-CT co-registration of determining the minimum ablation margin after thermal ablation for liver tumors | 1 year | 
| The time that is required for CT-CT co-registration | The time that is required for CT-CT co-registration | 1 year | 
| Quantitatively assessed ablation margin | Percentage of local recurrence per group as categorized according to ablation margin: <0mm, 0-5mm, >5mm | 1 year |