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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma; Liver Metastases; Liver Cancer; Liver Metastasis Colon Cancer

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 Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Coosje A. M. Verhagen, Drs.; Phone Number: +31-71-5264376; Email: c.a.m.verhagen@lumc.nl
• Study Contact Backup: Name: Ariadne L. Velden, van der, Drs.; Phone Number: +31(0)43-3876910; Email: lisa.van.der.velden@mumc.nl

Study Locations

• Netherlands
  • Leiden, Netherlands
    • Recruiting
    • Leiden University Medical Centre
    • Contact: Coosje A. M. Verhagen, Drs.; Phone Number: +31633691357; Email: c.a.m.verhagen@lumc.nl
    • Contact: Mark C. Burgmans, Md, PhD; Phone Number: +31-71-5264376; Email: M.C.Burgmans@lumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: Philips Healthcare; European Commission
• Investigators: Principal Investigator: Mark C. Burgmans, MD PhD, Leiden univeristy medical centre; Principal Investigator: Christiaan van der Leij, MD PhD, Maastricht University Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: 133356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No