跳至主要内容
临床试验/NCT06179602
NCT06179602招募中不适用

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

Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
1
主要终点
Efficacy as assessed by local recurrence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Patients lacking capacity to give informed consent.

结局指标

主要结局

Efficacy as assessed by local recurrence

时间窗: Throughout the entire four-year study period

Efficacy as assessed by overall survival

时间窗: Throughout the entire four-year study period

Efficacy as assessed by time-to-recurrence

时间窗: Throughout the entire four-year study period

Efficacy as assessed by disease-free-survival

时间窗: Throughout the entire four-year study period

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

时间窗: Throughout the entire four-year study period

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

次要结局

未报告次要终点

研究者

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark C Burgmans, MD PhD

Dr. M. C. Burgmans, MD PhD

Leiden University Medical Center

研究点 (1)

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