PDF(Pubmed)
Abstract：
UNASSIGNED: Radiotherapy is a standard treatment modality in cancer therapy, particularly for lung cancer. Diffusing alpha-emitters Radiation Therapy sources (hereafter, \"Alpha DaRTs\") are fixed with Ra-244 (half-life =3.6 days) that releases alpha-emitting atoms into the tumor tissue to an effective range of a few millimeters.
UNASSIGNED: The feasibility, usability, and safety of Alpha DaRTs deployment and implantation via bronchoscopy into the lung parenchyma and mediastinum in a big animal model of healthy swine was studied in two phases: (I) inert and (II) active Alpha DaRTs deployment. The Alpha DaRTs were inserted in both individual and cluster patterns based on a predefined plan. Swine health was monitored throughout the study. The usability of bronchoscopic deployment and implantation was evaluated using a user questionnaire. The movement and migration of the Alpha DaRTs were assessed. Necropsy was performed, and lungs were evaluated via gross pathology and histopathology.
UNASSIGNED: A total of 158 Alpha DaRTs were inserted successfully in the lung parenchyma and mediastinum of five swine in two phases. It was possible to deliver and place the Alpha DaRTs in clusters of no more than 4 mm distance between the Alpha DaRTs. No adverse event or change in the health and general condition of animals was observed. Hematologic evaluation did not show any clinically significant abnormality related to the Alpha DaRTs. Histopathology demonstrated local mild inflammatory changes, minimal fibrosis, and dystrophic mineralization with giant cells. Minimal movement and no migration of Alpha DaRTs were observed.
UNASSIGNED: Bronchoscopic deployment of Alpha DaRTs in the lung parenchyma and mediastinum of the porcine animal is feasible, precise, and safe.
UNASSIGNED: The feasibility, usability, and safety of Alpha DaRTs deployment and implantation via bronchoscopy into the lung parenchyma and mediastinum in a big animal model of healthy swine was studied in two phases: (I) inert and (II) active Alpha DaRTs deployment. The Alpha DaRTs were inserted in both individual and cluster patterns based on a predefined plan. Swine health was monitored throughout the study. The usability of bronchoscopic deployment and implantation was evaluated using a user questionnaire. The movement and migration of the Alpha DaRTs were assessed. Necropsy was performed, and lungs were evaluated via gross pathology and histopathology.
UNASSIGNED: A total of 158 Alpha DaRTs were inserted successfully in the lung parenchyma and mediastinum of five swine in two phases. It was possible to deliver and place the Alpha DaRTs in clusters of no more than 4 mm distance between the Alpha DaRTs. No adverse event or change in the health and general condition of animals was observed. Hematologic evaluation did not show any clinically significant abnormality related to the Alpha DaRTs. Histopathology demonstrated local mild inflammatory changes, minimal fibrosis, and dystrophic mineralization with giant cells. Minimal movement and no migration of Alpha DaRTs were observed.
UNASSIGNED: Bronchoscopic deployment of Alpha DaRTs in the lung parenchyma and mediastinum of the porcine animal is feasible, precise, and safe.
摘要：
■放射治疗是癌症治疗的标准治疗方式，特别是肺癌。扩散α发射体放射治疗源(以下，“AlphaDaRTs”）用Ra-244（半衰期=3.6天）固定，可将α发射原子释放到肿瘤组织中，有效范围为几毫米。
■可行性，可用性，在健康猪的大型动物模型中，通过支气管镜将AlphaDaRTs部署和植入肺实质和纵隔的安全性进行了两个阶段的研究：（I）惰性和（II）主动AlphaDaRTs部署。AlphaDaRT基于预定义的计划以个体和集群模式插入。在整个研究中监测猪健康。使用用户问卷评估支气管镜部署和植入的可用性。评估AlphaDaRTs的移动和迁移。进行尸检,和肺通过大体病理学和组织病理学进行评估。
■在五只猪的肺实质和纵隔中成功插入了总共158个AlphaDaRTs，分两个阶段。可以在AlphaDaRT之间的距离不超过4mm的集群中递送和放置AlphaDaRT。没有观察到不良事件或动物的健康和一般状况的变化。血液学评估未显示与AlphaDaRTs相关的任何临床显着异常。组织病理学显示局部轻度炎症改变，最小纤维化，和巨细胞营养不良的矿化。观察到AlphaDaRTs的最小移动和无迁移。
■在猪的肺实质和纵隔的支气管镜下展开AlphaDaRTs是可行的，精确，和安全。
■可行性，可用性，在健康猪的大型动物模型中，通过支气管镜将AlphaDaRTs部署和植入肺实质和纵隔的安全性进行了两个阶段的研究：（I）惰性和（II）主动AlphaDaRTs部署。AlphaDaRT基于预定义的计划以个体和集群模式插入。在整个研究中监测猪健康。使用用户问卷评估支气管镜部署和植入的可用性。评估AlphaDaRTs的移动和迁移。进行尸检,和肺通过大体病理学和组织病理学进行评估。
■在五只猪的肺实质和纵隔中成功插入了总共158个AlphaDaRTs，分两个阶段。可以在AlphaDaRT之间的距离不超过4mm的集群中递送和放置AlphaDaRT。没有观察到不良事件或动物的健康和一般状况的变化。血液学评估未显示与AlphaDaRTs相关的任何临床显着异常。组织病理学显示局部轻度炎症改变，最小纤维化，和巨细胞营养不良的矿化。观察到AlphaDaRTs的最小移动和无迁移。
■在猪的肺实质和纵隔的支气管镜下展开AlphaDaRTs是可行的，精确，和安全。
