Prospective Cohort Study on Thermal Ablation of Malignant Liver Tumors

NCT ID: NCT06179602

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2028-01-01

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.

Conditions

Liver Cancer; Liver Metastases; Liver Metastasis Colon Cancer; Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Healthcare

INDUSTRY

Sponsor Role: collaborator

European Commission

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mark C Burgmans, MD PhD

Dr. M. C. Burgmans, MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark C. Burgmans, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden univeristy medical centre

Christiaan van der Leij, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Centre

Locations

Leiden University Medical Centre

Leiden, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Coosje A. M. Verhagen, Drs.

Role: CONTACT

c.a.m.verhagen@lumc.nl

+31-71-5264376

Ariadne L. Velden, van der, Drs.

Role: CONTACT

lisa.van.der.velden@mumc.nl

+31(0)43-3876910

Facility Contacts

Coosje A. M. Verhagen, Drs.

Role: primary

c.a.m.verhagen@lumc.nl

+31633691357

Mark C. Burgmans, Md, PhD

Role: backup

M.C.Burgmans@lumc.nl

+31-71-5264376

References

van der Velden AL, Verhagen CAM, Gholamiankhah F, Rahmani H, van Dam RM, van Duijn-de Vreugd JJ, Simon SR, Hendriks P, van Erp GCM, Knapen RRMM, Volmer L, Overduin K, Braak JPBM, Bale R, Laimer G, Lanocita R, Meijerink MR, Kampfer Y, Denys A, Littler P, Sternberg B, Kobeiter H, Smits MLJ, van Strijen MJL, Pieterman KJ, Broersen A, Dijkstra J, Brecheisen R, Burgmans MC, van der Leij C. Prospective Registry Study on Thermal Liver Ablation of Primary and Secondary Liver Tumours Named the A-IMAGIO Study. Cardiovasc Intervent Radiol. 2025 Aug;48(8):1193-1199. doi: 10.1007/s00270-025-04093-9. Epub 2025 Jun 23.

Reference Type: DERIVED

PMID: 40550852 (View on PubMed)

Other Identifiers

133356

Identifier Type: -

Identifier Source: org_study_id