About this trial
To achieve adequate tumor treatment coverage with sufficient minimal ablation margins, several steps are required: firstly, it is critical to define tumor boundaries and extent on intra-procedural CT image; secondly, accurate planning, targeting, and confirmation of ablation probe placement within the tumor; thirdly, the use of an intra-procedural imaging assessment method to evaluate minimal ablation margins is required to define whether sufficient minimal ablation margins was obtained or if additional ablation is needed. Taking all together, those factors points to the need of having a high-precision ablation methodology for intra-procedural planning, monitoring, and ablation margin assessment. Currently, such methods are only utilized in isolation and the benefit of a combined and standardized procedure workflow is unknown. Therefore, our primary goal of this single-arm clinical trial is to investigate the technical efficacy of a high-precision liver ablation technique comprised by stereotactic-guidance, CT during hepatic arteriography-based imaging analysis, and computer-based software assessment of ablation margins for the treatment of patients referred to ablation for the treatment of primary and secondary liver cancers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients presenting with up to 5 colorectal liver metastasis measuring up to 5 cm who are referred to percutaneous ablation;
Ability to completely cover the target tumor with at least a 5 mm ablation margin as determined per pre-procedure cross-sectional imaging;
Distance to central bile ducts > 1 cm;
Adequate glomerular filtration rate (GFR > 40) and no severe allergies to iodine contrast-media;
Disqualifiers
Use of other prior or concomitant local therapy at the target tumor(s).
Active bacterial infection or fungal infection on the day of the ablation.
Platelet < 50,000/mm3.
INR > 1.5
Trial design
Single group
Treatments tested in this trial
Liver ablation
Procedure/SurgeryAblation needle placement An image-guidance device be used for planning of the procedure and for placement of the ablation needle
Treatment groups
Trial outcomes
Primary outcomes
Quality of Life Questionnaire (EQ-5D-3L)
The scale is numbered from 0-100 (100 means the best health you can imagine. 0 means the worst health you can imagine)
Sponsors and contacts
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