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NCT Number: NCT06179602

Prospective Cohort Study on Thermal Ablation of Malignant Liver Tumors

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.

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Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Efficacy as assessed by local recurrence

    Time frame: Throughout the entire four-year study period

  2. Efficacy as assessed by time-to-recurrence

    Time frame: Throughout the entire four-year study period

  3. Efficacy as assessed by disease-free-survival

    Time frame: Throughout the entire four-year study period

  4. Efficacy as assessed by overall survival

    Time frame: Throughout the entire four-year study period

  5. Safety as assessed by complications according to CTCAE v6.0.

    Time frame: Throughout the entire four-year study period

    Treatment related adverse events are defined as grade 3-4 adverse events and serious

Study contacts

Contact information is provided by the study sponsor or research team.

Ariadne L. Velden, van der, Drs.

CONTACT

[email protected]

+31(0)43-3876910

Coosje A. M. Verhagen, Drs.

CONTACT

[email protected]

+31-71-5264376

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • European Commission
  • Philips Healthcare

Registry information

Official study title

Prospective Cohort Study on Thermal Ablation of Malignant Liver Tumors Within the IMAGIO Project (A-IMAGIO)

Acronym: A-IMAGIO

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Dec 22, 2023
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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