背景:迄今为止,根治性手术仍然是早期肺癌患者的最佳治疗选择。在肺小病变患者中,应越来越多地选择电视胸腔镜手术(VATS)作为开胸手术的基本替代方案,因为它可以减少术后疼痛,提高生活质量.这种情况必然会增加胸外科医师实施新的定位技术的需求。传统的近红外(NIR)吲哚菁绿(ICG)方法在深度癌症识别中表现出明显的局限性。主要是由于其固有的低深度组织渗透。同样,通过ICG方法进行的淋巴结前哨入路被证明是无效的,主要是由于跟踪器的非特异性和肺淋巴结引流的不规则路径。我们的研究旨在评估西妥昔单抗-IRDye800CW标记肺结节和纵隔淋巴结的有效性。
方法:这项研究被定义为开放标签,单臂,单阶段II期试验评估西妥昔单抗-IRDye800CW在检测正在接受电视胸腔镜手术(VATS)的肺癌患者的肿瘤和淋巴结转移中的有效性.西妥昔单抗是一种单克隆抗体,抑制,并降解EGFR。IRDye®800CW,吲哚菁型近红外荧光团,与其他NIR染料相比,组织穿透性增强。与临床批准的单克隆抗体抗表皮生长因子EGFR西妥昔单抗(西妥昔单抗-IRDye800)的组合已显示出有希望的结果,作为不同癌症类型的特异性跟踪器(即,大脑,胰腺,头部,和脖子)。该研究的主要结果集中在手术期间使用近红外相机检测到的肺结节患者的比例。次要结果包括广泛的项目,包括NIR相机在手术过程中检测到意外癌症定位的患者比例和手术切缘阴性的患者比例,评估插入NIR摄像机与结节可视化之间的时间以及在药物输注期间和之后评估的药物可能的发病率。
背景:该试验已获得都灵大学道德委员会的批准(都灵,意大利)和意大利药品管理局(AIFA)。研究结果将作为会议演讲的方法论论文撰写,并在同行评审的期刊上发表。AziendaOspedaliera大学向都灵致敬,都灵大学,AIRC公众参与部门将帮助确定如何最好地宣传调查结果。试用登记EudraCT202,100,645,430。
结果:govNCT06101394(2023年10月23日)。
BACKGROUND: To date, radical surgery remains the best curative option in patients with early-stage lung cancer. In patients with small lung lesions, video-assisted thoracic surgery (VATS) should be increasingly chosen as a fundamental alternative to thoracotomy as it is associated with less postoperative pain and better quality of life. This scenario necessarily increases the need for thoracic surgeons to implement new localization techniques. The conventional near-infrared (NIR) indocyanine green (ICG) method demonstrated a significant limitation in deep cancer recognition, principally due to its intrinsic low-depth tissue penetration. Similarly, the lymph-node sentinel approach conducted by the ICG method was demonstrated to be inefficient, mainly due to the non-specificity of the tracker and the irregular pathway of pulmonary lymph node drainage. Our
study aims to evaluate the effectiveness of Cetuximab- IRDye800CW in marking lung nodules and mediastinal lymph nodes.
METHODS: This
study is defined as an open-label, single-arm, single-stage phase II
trial evaluating the effectiveness of Cetuximab-IRDye800CW in detecting tumors and lymph-node metastases in patients with lung cancer who are undergoing video-assisted thoracic surgery (VATS). Cetuximab is a monoclonal antibody that binds, inhibits, and degrade the EGFR. The IRDye® 800CW, an indocyanine-type NIR fluorophore, demonstrated enhanced tissue penetration compared to other NIR dyes. The combination with the clinical approved monoclonal antibody anti-epidermal growth factor EGFR Cetuximab (Cetuximab-IRDye800) has shown promising results as a specific tracker in different cancer types (i.e., brain, pancreas, head, and neck). The
study\'s primary outcome is focused on the proportion of patients with lung nodules detected during surgery using an NIR camera. The secondary outcomes include a broad spectrum of items, including the proportion of patients with detection of unexpected cancer localization during surgery by NIR camera and the proportion of patients with negative surgical margins, the evaluation of the time spawns between the insertion of the NIR camera and the visualization of the nodule and the possible morbidity of the drug assessed during and after the drug infusion.
BACKGROUND: This
trial has been approved by the Ethical Committee of Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino (Torino, Italy) and by the Italian Medicines Agency (AIFA). Findings will be written as methodology papers for conference presentations and published in peer-reviewed journals. The Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino, the University of Torino, and the AIRC Public Engagement Divisions will help identify how best to publicize the findings.Trial registration EudraCT 202,100,645,430.
RESULTS: gov NCT06101394 (October 23, 2023).