HCC
Conditions
Brief summary
A pre- and postablation scan will be made intraprocedurally to investigate the feasibility of intraprocedural ablation verification assessment using coregistration software
Interventions
DIAGNOSTIC_TESTAdditional intraprocedural pre-ablation CT-scan
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.
Sponsors
Mirada Medical
Leiden University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
post-procedural an assessment will be done of the ablation completeness using registration software. The actual ablation verification will be done qualitatively by the treating physician.
Intervention model description
prospective, single blind, single-arm, phase II stud
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the use of co-registration software (>80%) | 1 year | The proportion of patients in whom reliable co-registration of pre- and post-ablation CT images is feasible |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter and intra-observer variability | 1 year | Inter- and intraobserver variability of CT-CT co-registration of determining the minimum ablation margin after thermal ablation for liver tumors |
| The time that is required for CT-CT co-registration | 1 year | The time that is required for CT-CT co-registration |
| Quantitatively assessed ablation margin | 1 year | Percentage of local recurrence per group as categorized according to ablation margin: \<0mm, 0-5mm, \>5mm |
Countries
Netherlands
Outcome results
None listed