PDF(Pubmed)
Abstract：
Background: Intravenously administered indocyanine green (ICG) accumulates in lung tumors, facilitating their detection via a fluorescence spectrum measurement. This method aids in identifying tumor locations that are invisible to the naked eye. We aim to determine the optimal ICG dose and administration method for accurate tumor identification during lung resection surgeries, utilizing a novel ICG fluorescence spectroscopy system for precise tumor localization. Materials and Methods: ICG should be dissolved in the provided solution or distilled water and administered intravenously approximately 24 h before surgery, beginning with an initial dose of 0.5 mg/kg. If the tumor detection rate is insufficient, the dose may be gradually increased to a maximum of 5.0 mg/kg to determine the optimal dosage for effective tumor detection. This fluorescence spectroscopy during surgery may reveal additional lesions that remain undetected in preoperative assessments. The primary endpoint includes the correct diagnostic rate of tumor localization. The secondary endpoints include the measurement of the intraoperative ICG fluorescence spectral intensity in lung tumors, the assessment of the operability and safety of intraperitoneal ICG administrations, the measurement of the ICG fluorescence spectral intensity in surgical specimens, the comparison of the spectral intensity in lung tissues during collapse and expansion, the correlation between ICG camera images and fluorescence spectral intensity, and the comparison of fluorescence analysis results with histopathological findings. The trial has been registered in the jRCT Clinical Trials Registry under the code jRCTs011230037. Results and Conclusions: This trial aims to establish an effective methodology for localizing and diagnosing malignant lung tumors, thereby potentially improving surgical outcomes and refining treatment protocols.
摘要：
背景：静脉注射吲哚菁绿（ICG）在肺部肿瘤中积聚，通过荧光光谱测量促进它们的检测。该方法有助于识别肉眼不可见的肿瘤位置。我们的目标是确定在肺切除手术期间准确识别肿瘤的最佳ICG剂量和给药方法，利用新型ICG荧光光谱系统进行精确的肿瘤定位。材料和方法：ICG应溶解在提供的溶液或蒸馏水中，并在手术前约24小时静脉内给药。以0.5mg/kg的初始剂量开始。如果肿瘤检出率不足，剂量可逐渐增加至最大5.0mg/kg,以确定有效肿瘤检测的最佳剂量。手术期间的这种荧光光谱可能会显示在术前评估中未检测到的其他病变。主要终点包括肿瘤定位的正确诊断率。次要终点包括测量肺肿瘤的术中ICG荧光光谱强度，评估腹膜内ICG给药的可操作性和安全性，手术标本中ICG荧光光谱强度的测量，在塌陷和扩张期间肺组织的光谱强度的比较，ICG相机图像与荧光光谱强度之间的相关性，荧光分析结果与组织病理学结果的比较。该试验已在jRCT临床试验注册中心注册，代码为jRCTs011230037。结果与结论：本试验旨在建立一种定位和诊断肺部恶性肿瘤的有效方法。从而潜在地改善手术结果和完善治疗方案。
