Annotations for A Randomized Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab in Patients With Advanced Non-small Cell Lung Cancer

This dataset contains image annotations derived from the NCI Clinical Trial "<a href="http://doi.org/10.7937/DT39-JS04">A Randomized Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab in Patients With Advanced Non-small Cell Lung Cancer</a>”.  This dataset was generated as part of an NCI project to augment TCIA datasets with annotations that will improve their value for cancer researchers and AI developers.<h3><strong>Annotation Protocol</strong></h3>For each patient, all scans were reviewed to identify and annotate the clinically relevant time points and sequences/series. Scans were initially annotated by an international team of radiologists holding MBBS degrees or higher, which were then reviewed by US-based board-certified radiologists to ensure accuracy. In a typical patient, all available time points were annotated. Every exam from the first available time point was annotated. One additional time point was annotated for each patient. The <a href="https://nctn-data-archive.nci.nih.gov/node/850">clinical data in the NCTN Archive</a> was utilized to help determine the first evidence of disease progression. The first time point demonstrating disease progression was annotated. If that document was not accurate and did not demonstrate disease progression, then later time points were reviewed to assess for disease progression and the first time point demonstrating disease progression was annotated. If there was no evidence of disease progression on any time point, then the last available time point was annotated. Again, every exam from each chosen time point was annotated. For example, if there was a CT and a PET/CT, the PET was annotated along with one CT. If there was an MRI, that was annotated as well.The following annotation rules were followed:<ol><li>PERCIST criteria was followed for PET imaging. Specifically, the lesions estimated to have the most elevated SUVmax were annotated.</li><li>RECIST 1.1 was otherwise generally followed for any MR and CT imaging. A maximum of 5 lesions were annotated per patient scan (timepoint); no more than 2 per organ. The same 5 lesions were annotated at each time point. Lymph nodes were however annotated if > 1 cm in short axis. Other lesions were annotated if > 1 cm. If the primary lesion is < 1 cm, it was still annotated. If there was evidence of disease progression with new lesions then additional annotations were allowed to demonstrate that progression. A representative sample of the new lesions was annotated at the radiologist's discretion.</li><li>Lesions were annotated in the axial plane. If no axial plane was available, lesions were annotated in the coronal plane.</li><li>MRIs were annotated using the T1-weighted post contrast sequence, fat saturated if available. If not available, T2-weighted sequences were utilized.</li><li>CTs were annotated using the axial post contrast series. If not available, the non contrast series was annotated.</li><li>PET/CTs were annotated on the CT and attenuation corrected PET images. However, if the post contrast CT was performed the same day as the PET/CT, the non contrast CT portion of the PET/CT was annotated.</li><li>Lesions were labeled separately.</li><li>The volume of each annotated lesion was calculated and reported in cubic centimeters [cc] in a dataset metadata report.</li><li>Seed points were automatically generated but reviewed by a radiologist.</li><li>A “negative” annotation was created for any exam without findings.</li></ol>At each time point:<ol><li>A seed point (kernel) was created for each segmented structure. The seed points for each segmentation are provided in a separate DICOM RTSS file.</li><li>SNOMED-CT “Anatomic Region Sequence” and “Segmented Property Category Code Sequence” and codes were inserted for all segmented structures.</li><li>“Tracking ID” and “Tracking UID” tags were inserted for each segmented structure to enable longitudinal lesion tracking.</li><li>Imaging time point codes were inserted to help identify each annotation in the context of the clinical trial assessment protocol.<ol><li>“Clinical Trial Time Point ID” was used to encode time point type using one of the following strings as applicable: “pre-dose” or “post-chemotherapy”</li><li>Content Item in “Acquisition Context Sequence” was added containing "Time Point Type" using Concept Code Sequence (0040,A168) selected from:<ol><li>(255235001, SCT, “Pre-dose”)</li><li>(262502001, SCT, "Post-chemotherapy")</li></ol></li></ol></li></ol><h3>Important supplementary information and sample code</h3><ol><li>A spreadsheet containing key details about the annotations is available in the <strong>Data Access</strong> section below.</li><li>A Jupyter notebook demonstrating how to use the <a href="https://wiki.cancerimagingarchive.net/display/NBIA/NBIA+Data+Retriever+Command-Line+Interface+Guide">NBIA Data Retriever Command-Line Interface</a> application and the <a href="https://wiki.cancerimagingarchive.net/display/Public/NBIA+Search+with+Authentication+REST+API+Guide">REST API</a> to access these data can be found in the <strong>Additional Resources</strong> section below.</li></ol>

本数据集收录了源自美国国家癌症研究所（NCI）临床试验“A Randomized Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab in Patients With Advanced Non-small Cell Lung Cancer”的图像标注数据。该数据集的生成是作为NCI项目的一部分，旨在通过添加标注以提升TCIA数据集对癌症研究人员和AI开发者的价值。标注协议如下：对每位患者，对所有扫描图像进行审查，以识别并标注临床相关的时点和序列/系列。初期的标注由持有MBBS学位或以上资质的国际放射学专家团队完成，随后由美国认证的放射学专家进行复核以确保标注的准确性。在典型患者中，所有可用的时点均进行标注。从第一个可用的时点开始，对每一次检查进行标注。每位患者额外标注一个时点。利用NCTN档案中的临床数据（<a href="https://nctn-data-archive.nci.nih.gov/node/850">临床数据在NCTN档案中</a>）以帮助确定疾病进展的首个证据。标注显示疾病进展的第一个时点。如果该文件不准确且未显示疾病进展，则审查后续时点以评估疾病进展，并标注显示疾病进展的第一个时点。如果任何时点均无疾病进展的证据，则标注最后可用的时点。再次强调，从每个选定的时点开始，对每一次检查进行标注。例如，如果有CT和PET/CT，则对PET进行标注，并附带一个CT。如果有MRI，则对其进行标注。以下标注规则被遵循：1. 对于PET成像，遵循PERCIST标准。具体而言，标注估计SUVmax最高的病变。2. 对于任何MR和CT成像，通常遵循RECIST 1.1标准。每位患者扫描（时点）最多标注5个病变，每个器官不超过2个。在每个时点标注相同的5个病变。如果淋巴结短轴直径大于1厘米，则标注淋巴结。其他病变如果直径大于1厘米，则进行标注。如果原发性病变小于1厘米，仍进行标注。如果有新病变的证据表明疾病进展，则允许进行额外的标注以展示该进展。放射科医生根据判断对新的病变样本进行标注。3. 病变在轴向平面上进行标注。如果无轴向平面可用，则在冠状平面上标注病变。4. 使用T1加权对比增强序列对MRI进行标注，如果可用，则使用脂肪饱和序列。如果不可用，则使用T2加权序列。5. 使用对比增强的轴向序列对CT进行标注。如果不可用，则标注非对比序列。6. 在CT和衰减校正的PET图像上对PET/CT进行标注。然而，如果对比增强CT与PET/CT在同一天进行，则标注PET/CT的非对比CT部分。7. 病变单独标注。8. 每个标注病变的体积计算并报告为立方厘米[cc]，在数据集元数据报告中列出。9. 自动生成种子点，但由放射科医生进行复核。10. 对无发现物的任何检查创建“阴性”标注。在每个时点：1. 为每个分割结构创建一个种子点（核）。每个分割的种子点以单独的DICOM RTSS文件提供。2. 为所有分割结构插入SNOMED-CT“解剖区域序列”和“分割属性类别代码序列”和代码。3. 为每个分割结构插入“跟踪ID”和“跟踪UID”标签，以实现纵向病变跟踪。4. 插入成像时点代码，以帮助在临床试验评估方案中识别每个标注。其中，“Clinical Trial Time Point ID”用于编码时点类型，使用以下字符串之一进行编码：“pre-dose”或“post-chemotherapy”。5. 在“Acquisition Context Sequence”中添加包含“Time Point Type”的内容项，使用概念代码序列（0040,A168）选择，从以下选项中选择：<ol><li>(255235001, SCT, “Pre-dose”)</li><li>(262502001, SCT, “Post-chemotherapy”)</li></ol></li></ol><h3>重要补充信息和示例代码</h3><ol><li>包含标注关键细节的电子表格可在下方的“数据访问”部分找到。</li><li>在“附加资源”部分，可以找到演示如何使用<a href="https://wiki.cancerimagingarchive.net/display/NBIA/NBIA+Data+Retriever+Command-Line+Interface+Guide">NBIA数据检索命令行界面</a>应用程序和<a href="https://wiki.cancerimagingarchive.net/display/Public/NBIA+Search+with+Authentication+REST+API+Guide">REST API</a>访问这些数据的Jupyter笔记本。</li></ol>