Study Protocol COVER-ALL: Clinical Impact of a Volumetric Image Method for Confirming Tumour Coverage with Ablation on Patients with Malignant Liver Lesions.
Study Protocol COVER-ALL: Clinical Impact of a Volumetric Image Method for Confirming Tumour Coverage with Ablation on Patients with Malignant Liver Lesions.
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DOI：
10.1007/s00270-022-03255-3
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发表时间：
2022-12
影响因子：
2.9
通讯作者：
Odisio, Bruno C.
中科院分区：
文献类型：
--
作者：
Lin, Yuan-Mao;Paolucci, Iwan;Anderson, Brian M.;O'Connor, Caleb S.;Rigaud, Bastien;Briones-Dimayuga, Maria;Jones, Kyle A.;Brock, Kristy K.;Fellman, Bryan M.;Odisio, Bruno C.
关键词：
这项研究旨在评估一种新的消融确认(AC)方法的术中使用，该方法包括生物力学可变形图像配准和基于人工智能的自动分割，以及通过定量三维MAM(3D-MAM)CT生成的评估对肿瘤覆盖的影响。这项单中心、随机、II期意向治疗试验招募了100名患有原发和继发性肝肿瘤(≤3肿瘤，直径1-5厘米)的受试者，接受微波或射频消融，目标是达到≥5 mm的最大平均动脉压。对于实验臂，本文提出的新型AC方法被用于烧蚀敷贴器(S)的放置验证和3D-MAM评估。对于对照组，通过目视检查和基于解剖标志的定量测量，辅助消融前和消融后对比增强CT图像的共同配准来评估相同的变量。主要目的是评估所提出的AC方法对3D-MAM的影响。次要目标是2年无LTP生存率、并发症发生率、生活质量、肝功能、其他肿瘤学结果，以及AC方法对手术流程的影响。这项覆盖所有的试验将提供基于生物力学可变形配准的消融确认方法的信息，该方法结合了基于人工智能的自动分割来改进3D-MAM，这可能会转化为肝脏消融效果的改善。这项覆盖所有试验的目的是提供关于一种新的术中AC方法在改善3D-MAM方面的作用的信息，这可能会转化为改善肝脏消融效果的方法。
This study aims to evaluate the intra-procedural use of a novel ablation confirmation (AC) method, consisting of biomechanical deformable image registration incorporating AI-based auto-segmentation, and its impact on tumor coverage by quantitative three-dimensional MAM (3D-MAM) CT-generated assessment. This single-center, randomized, phase II, intent-to-treat trial is enrolling 100 subjects with primary and secondary liver tumors (≤3 tumors, 1–5 cm diameter) undergoing microwave or radiofrequency ablation with a goal of achieving ≥ 5 mm MAM. For the experimental arm, the proposed novel AC method is utilized for ablation applicator(s) placement verification and 3D-MAM assessment. For the control arm, the same variables are assessed by visual inspection and anatomical landmarks-based quantitative measurements aided by co-registration of pre- and post-ablation contrast-enhanced CT images. The primary objective is to evaluate the impact of the proposed AC method on the 3D-MAM. Secondary objectives are 2-year LTP-free survival, complication rates, quality of life, liver function, other oncological outcomes, and impact of AC method on procedure workflow. The COVER-ALL trial will provide information on the role of a biomechanical deformable registration-based ablation confirmation method incorporating AI-based auto-segmentation for improving 3D-MAM, which might translate in improvements of liver ablation efficacy. The COVER-ALL trial aims to provide information on the role of a novel intra-procedural AC method for improving 3D-MAM, which might translate in improvements of liver ablation efficacy.
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作者：
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通讯作者：
Odisio, Bruno C.
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