Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands.
Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands.
BMC Cancer. 2021 Oct 18;21(1):1116. doi: 10.1186/s12885-021-08833-1.
Abdominal computed tomography (CT) is the standard imaging method for patients with suspected colorectal liver metastases (CRLM) in the diagnostic workup for surgery or thermal ablation. Diffusion-weighted and gadoxetic-acid-enhanced magnetic resonance imaging (MRI) of the liver is increasingly used to improve the detection rate and characterization of liver lesions. MRI is superior in detection and characterization of CRLM as compared to CT. However, it is unknown how MRI actually impacts patient management. The primary aim of the CAMINO study is to evaluate whether MRI has sufficient clinical added value to be routinely added to CT in the staging of CRLM. The secondary objective is to identify subgroups who benefit the most from additional MRI.
In this international multicentre prospective incremental diagnostic accuracy study, 298 patients with primary or recurrent CRLM scheduled for curative liver resection or thermal ablation based on CT staging will be enrolled from 17 centres across the Netherlands, Belgium, Norway, and Italy. All study participants will undergo CT and diffusion-weighted and gadoxetic-acid enhanced MRI prior to local therapy. The local multidisciplinary team will provide two local therapy plans: first, based on CT-staging and second, based on both CT and MRI. The primary outcome measure is the proportion of clinically significant CRLM (CS-CRLM) detected by MRI not visible on CT. CS-CRLM are defined as liver lesions leading to a change in local therapeutical management. If MRI detects new CRLM in segments which would have been resected in the original operative plan, these are not considered CS-CRLM. It is hypothesized that MRI will lead to the detection of CS-CRLM in ≥10% of patients which is considered the minimal clinically important difference. Furthermore, a prediction model will be developed using multivariable logistic regression modelling to evaluate the predictive value of patient, tumor and procedural variables on finding CS-CRLM on MRI.
The CAMINO study will clarify the clinical added value of MRI to CT in patients with CRLM scheduled for local therapy. This study will provide the evidence required for the implementation of additional MRI in the routine work-up of patients with primary and recurrent CRLM for local therapy.
The CAMINO study was registered in the Netherlands National Trial Register under number NL8039 on September 20th 2019.
腹部计算机断层扫描（CT）是疑似结直肠癌肝转移（CRLM）患者在手术或热消融诊断工作中标准的影像学方法。肝脏的扩散加权和钆塞酸增强磁共振成像（MRI）越来越多地用于提高肝脏病变的检出率和特征描述。与 CT 相比，MRI 在 CRLM 的检测和特征描述方面更具优势。然而，目前尚不清楚 MRI 实际上如何影响患者的管理。CAMINO 研究的主要目的是评估 MRI 是否具有足够的临床附加价值，以便在 CRLM 的分期中常规添加到 CT 中。次要目标是确定从额外的 MRI 中受益最多的亚组。
在这项国际多中心前瞻性增量诊断准确性研究中，将从荷兰、比利时、挪威和意大利的 17 个中心招募 298 名接受根治性肝切除术或热消融治疗的原发性或复发性 CRLM 患者。所有研究参与者将在局部治疗前接受 CT、扩散加权和钆塞酸增强 MRI 检查。当地多学科团队将提供两种局部治疗计划：首先，基于 CT 分期，其次，基于 CT 和 MRI。主要结局指标是 MRI 检测到 CT 上不可见的临床显著 CRLM（CS-CRLM）的比例。CS-CRLM 定义为导致局部治疗管理改变的肝病变。如果 MRI 在原始手术计划中切除的节段检测到新的 CRLM，则这些病变不被认为是 CS-CRLM。假设 MRI 将在≥10%的患者中检测到 CS-CRLM，这被认为是最小的临床重要差异。此外，将使用多变量逻辑回归建模来开发预测模型，以评估患者、肿瘤和程序变量对 MRI 上发现 CS-CRLM 的预测价值。
CAMINO 研究将阐明 MRI 对接受局部治疗的 CRLM 患者 CT 的临床附加价值。这项研究将为在原发性和复发性 CRLM 患者的局部治疗常规工作中实施额外的 MRI 提供所需的证据。
CAMINO 研究于 2019 年 9 月 20 日在荷兰国家试验注册中心以 NL8039 号注册。
