NCT06179602

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jan 2024Jan 2028

First Submitted

Initial submission to the registry

December 5, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

Expected
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

September 10, 2025

Status Verified

September 1, 2024

Enrollment Period

4 years

First QC Date

December 5, 2023

Last Update Submit

September 3, 2025

Conditions

Liver CancerLiver MetastasesLiver Metastasis Colon CancerHepatocellular Carcinoma

Outcome Measures

Primary Outcomes (5)

  • 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.

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

    Throughout the entire four-year study period

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients lacking capacity to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Centre

Leiden, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40550852DERIVED

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Mark C. Burgmans, MD PhD

    Leiden univeristy medical centre

    PRINCIPAL INVESTIGATOR

  • Christiaan van der Leij, MD PhD

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Coosje A. M. Verhagen, Drs.

CONTACT

+31-71-5264376c.a.m.verhagen@lumc.nl

Ariadne L. Velden, van der, Drs.

CONTACT

+31(0)43-3876910lisa.van.der.velden@mumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. M. C. Burgmans, MD PhD

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 22, 2023

Study Start

January 1, 2024

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

September 10, 2025

Record last verified: 2024-09

Locations

NL(1)