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一项名为A-IMAGIO研究的关于原发性和继发性肝肿瘤热消融的前瞻性注册研究。

Prospective Registry Study on Thermal Liver Ablation of Primary and Secondary Liver Tumours Named the A-IMAGIO Study.

作者信息

van der Velden A L, Verhagen C A M, Gholamiankhah F, Rahmani H, van Dam R M, van Duijn-de Vreugd J J, Simon S R, Hendriks P, van Erp G C M, Knapen R R M M, Volmer L, Overduin K, Braak J P B M, Bale R, Laimer G, Lanocita R, Meijerink M R, Kampfer Y, Denys A, Littler P, Sternberg B, Kobeiter H, Smits M L J, van Strijen M J L, Pieterman K J, Broersen A, Dijkstra J, Brecheisen R, Burgmans M C, van der Leij C

机构信息

Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+, Maastricht, The Netherlands.

GROW, School for Oncology and Reproduction, Maastricht University, Maastricht, The Netherlands.

出版信息

Cardiovasc Intervent Radiol. 2025 Jun 23. doi: 10.1007/s00270-025-04093-9.

Abstract

PURPOSE

The long-term objective of the Ablation-IMaging and Advanced Guidance for workflow optimization in Interventional Oncology (A-IMAGIO) project is to develop a standardized, accessible, low-complex, high-precision, end-to-end solution for treatment planning, needle guidance, and treatment evaluation for thermal liver ablation.

MATERIALS AND METHODS

This is a prospective, international, multicentre, observational registry study. Patients will be included with age ≥ 18 years, diagnosed with primary or secondary liver tumours, and undergoing thermal liver ablation. A detailed dataset of medical history, baseline clinical and imaging parameters, tumour characteristics, ablation technique/parameters, treatment outcomes, periprocedural images, and adverse events, will be collected for all participants. This data will be used to develop AI algorithms for prognostic modelling and quantitative imaging analysis. Additionally, costs associated with thermal liver ablation clinical pathway will be evaluated.

EXPECTED GAIN OF KNOWLEDGE

The results of this registry study are expected to provide profound insight in current variability among centres in performing thermal liver ablation, and identify best practices in order to eventually facilitate standardization and universally excellent clinical outcomes.

TRIAL REGISTRATION

National Institute of Health Clinical trial database (NCT06179602) https://clinicaltrials.gov/study/NCT06179602 .

摘要

目的

介入肿瘤学工作流程优化的消融成像与高级引导(A-IMAGIO)项目的长期目标是开发一种标准化、可获取、低复杂度、高精度的端到端解决方案,用于热消融治疗肝脏肿瘤的治疗规划、针引导和治疗评估。

材料与方法

这是一项前瞻性、国际性、多中心观察性注册研究。纳入年龄≥18岁、诊断为原发性或继发性肝脏肿瘤且正在接受肝脏热消融治疗的患者。将为所有参与者收集详细的病史、基线临床和影像参数、肿瘤特征、消融技术/参数、治疗结果、围手术期影像和不良事件数据集。这些数据将用于开发用于预后建模和定量影像分析的人工智能算法。此外,还将评估与肝脏热消融临床路径相关成本。

预期知识收获

该注册研究结果有望深入了解目前各中心在进行肝脏热消融治疗方面的差异,并确定最佳实践,最终促进标准化并实现普遍卓越的临床结果。

试验注册

美国国立卫生研究院临床试验数据库(NCT06179602)https://clinicaltrials.gov/study/NCT06179602

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