Liver CancerA-IMAGIONCT06179602
Prospective Cohort Study on Thermal Ablation of Malignant Liver Tumors
An observational study of Liver Cancer and Liver Metastases, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Liver Cancer, Liver Metastases, Liver Metastasis Colon Cancer
- How many people
- 1,500 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2024to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years or above
- Candidate for percutaneous thermal liver ablation as discussed in a multidisciplinary tumorboard (MDT)
- Informed consent
Who cannot join
- Patients lacking capacity to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Centre
Leiden
Coosje A. M. Verhagen, Drs., +31633691357, c.a.m.verhagen@lumc.nl
Mark C. Burgmans, Md, PhD, +31-71-5264376, M.C.Burgmans@lumc.nl
About this study
Official title: Prospective Cohort Study on Thermal Ablation of Malignant Liver Tumors Within the IMAGIO Project (A-IMAGIO)
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.
Read the 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.
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as assessed by local recurrence
Measured: Throughout the entire four-year study period
Efficacy as assessed by time-to-recurrence
Measured: Throughout the entire four-year study period
Efficacy as assessed by disease-free-survival
Measured: Throughout the entire four-year study period
Efficacy as assessed by overall survival
Measured: Throughout the entire four-year study period
Safety as assessed by complications according to CTCAE v6.0.
Treatment related adverse events are defined as grade 3-4 adverse events and serious
Measured: Throughout the entire four-year study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Jan 2024
- Primary completion15 Dec 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare, European Commission
- Responsible party
- Principal investigator, Mark C Burgmans, MD PhD, Leiden University Medical Center
- Investigators
- Mark C. Burgmans, MD PhD, Principal investigator, Leiden univeristy medical centreChristiaan van der Leij, MD PhD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179602
- Sponsor's protocol ID
- 133356
- Acronym
- A-IMAGIO
- Status last verified
- Sep 2024
- First submitted
- 5 Dec 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40550852
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on Thermal Ablation of Malignant Liver Tumors Within the IMAGIO Project (A-IMAGIO)
- ClinicalTrials.gov ID
- NCT06179602
- Acronym / sponsor ID
- A-IMAGIO / 133356
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Philips Healthcare, European Commission
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 18 years or above
- Candidate for percutaneous thermal liver ablation as discussed in a multidisciplinary tumorboard (MDT)
- Informed consent
Key exclusion criteria (1 listed)
- Patients lacking capacity to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy as assessed by local recurrence
Time frame: Throughout the entire four-year study period
Efficacy as assessed by time-to-recurrence
Time frame: Throughout the entire four-year study period
Efficacy as assessed by disease-free-survival
Time frame: Throughout the entire four-year study period
Efficacy as assessed by overall survival
Time frame: Throughout the entire four-year study period
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Derived from this study: PubMed 40550852van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark C. Burgmans, MD PhD principal investigator
Leiden univeristy medical centre
Christiaan van der Leij, MD PhD principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer and Liver Metastases, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Coosje A. M. Verhagen, Drs. (+31-71-5264376, c.a.m.verhagen@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy as assessed by local recurrence (time frame: Throughout the entire four-year study period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06179602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.