Clinical trial NCT06179602: Prospective Cohort Study on Thermal Ablation of Malignant Liver Tumors
Official title: Prospective Cohort Study on Thermal Ablation of Malignant Liver Tumors Within the IMAGIO Project (A-IMAGIO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cancer
Liver Metastases
Liver Metastasis Colon Cancer
Hepatocellular Carcinoma
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
name: European Commission
First posted: 2023-12-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with one or more primary or secondary liver malignancy who are candidates for thermal liver ablation as discussed in a multidisciplinary tumour board.

Brief 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.

Detailed description: This study is part of the IMAGIO (Imaging and advanced guidance for workflow optimization in interventional oncology) project. This project aims to leverage Interventional Oncology in the clinical setting to improve cancer survival outcomes, through minimally invasive, efficient and affordable care pathways for three disease states; liver cancer, lung cancer and sarcoma. In IMAGIO, top innovators in MedTech and Pharma and expert academic clinical centers will mature the next-generation interventional oncology imaging across the full spectrum, from pre-clinical developments to impact validation in clinical trials.

The objective of this study, A-IMAGIO, is to develop a standardized, accessible, low-complex, end-to-end solution for patient selection, treatment planning, needle guidance and treatment evaluation for thermal liver ablation.

One of the objectives is to integrate AI in the clinical workflow as a tool to assist operators in decision making throughout the entire process based on quantitative assessment. AI data analytics will be developed to guide decision making for personalized treatment together with algorithms that allow optimized treatment planning and automated quantitative treatment evaluation. Also, a computational model will be developed with input from radiomics and clinical data to identify patients at risk of recurrence after thermal ablation. The aim of the A-IMAGIO project is to conduct a large European observational cohort study and collect clinical and image data of patients treated with thermal ablation for liver tumors in order to develop and validate these AI algorithms. The database will be built by merging data from retrospective data and previous prospective clinical trials on thermal ablation of liver tumors. Further data will be collected through a prospective, multicenter, observational study. The long-term objective is to establish thermal ablation as the first line therapy for patients with both primary and secondary liver tumors. Therefore, we aim to develop a low-complexity-high-precision, accessible workflow that can be widely implemented in different centers performing thermal ablation.

Eligibility criteria: Inclusion Criteria:

* 18 years or above
* Candidate for percutaneous thermal liver ablation as discussed in a multidisciplinary tumorboard (MDT)
* Informed consent

Exclusion Criteria:

* Patients lacking capacity to give informed consent.

Primary outcomes:
measure: Efficacy as assessed by local recurrence
timeFrame: Throughout the entire four-year study period
measure: Efficacy as assessed by time-to-recurrence
timeFrame: Throughout the entire four-year study period
measure: Efficacy as assessed by disease-free-survival
timeFrame: Throughout the entire four-year study period
measure: Efficacy as assessed by overall survival
timeFrame: Throughout the entire four-year study period
measure: Safety as assessed by complications according to CTCAE v6.0.
timeFrame: Throughout the entire four-year study period
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
Study officials:
affiliation: Leiden univeristy medical centre
name: Mark C. Burgmans, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Centre
name: Christiaan van der Leij, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: