Prospective Cohort Study on Thermal Ablation of Malignant Liver Tumors

Condition(s) studied

Study summary

The endpoint of this study is to develop and validate algorithms, using artificial intelligence and machine learning, to optimize patient selection, treatment planning, treatment evaluation and outcome prediction in patients undergoing thermal ablation of a malignant liver tumor. The long-term objective is to establish thermal ablation as the treatment of choice for the vast majority of patients with a primary or secondary liver tumor by development of an accessible workflow that can be widely implemented in different centers performing thermal ablation. Over a time span of at least four years, data will be collected prospectively, encompassing patient information, tumor characteristics, and treatment details. Additionally, pre-, intra-, and post-procedural imaging will be systematically gathered.

Eligibility

Primary outcome measure(s)

• Efficacy as assessed by local recurrence — Throughout the entire four-year study period
• Efficacy as assessed by time-to-recurrence — Throughout the entire four-year study period
• Efficacy as assessed by disease-free-survival — Throughout the entire four-year study period
• Efficacy as assessed by overall survival — Throughout the entire four-year study period
• Safety as assessed by complications according to CTCAE v6.0. — Throughout the entire four-year study period
  Treatment related adverse events are defined as grade 3-4 adverse events and serious

Trial sites (1)

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