Annotations for Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor (AREN0534-Tumor-Annotations)

This dataset contains image annotations derived from the NCI Clinical Trial "Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor (AREN0534)”. The key objective of this project is to generate a large and highly curated imaging dataset of pediatric Wilms tumor patients with annotations suitable for cancer researchers and AI developers.

Annotation Protocol
For each patient, every DICOM Study and DICOM Series was reviewed to identify and annotate the clinically relevant time points and sequences. In a typical patient the following time points will be annotated:

Pre-surgical CT chest and CT/MRI abdomen
CT chest and/or CT/MRI abdomen at 6 weeks
Possible CT/MRI abdomen at 12 weeks.
Any negative imaging included past 12 weeks was annotated as negative. If any included imaging past 12 weeks is positive for tumor, the last positive exam was annotated.
In a typical patient the following annotation rules were followed:

The primary renal tumor(s) were annotated on the post-contrast axial series. Normal renal parenchyma were excluded.
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. RECIST 1.1 principles were followed for lesion annotation, however, if <5 lesions measuring >1 cm were present, then smaller lesions were annotated, again up to 2 lesions per organ or 5 lesions per patient scan. Bone lesions were included if other lesions were not present.
Lesions were labeled separately.
Seed points were automatically generated but reviewed by a radiologist.
At each time point:

A seed point (kernel) was created for each segmented structure. The seed points for each segmentation are provided in a separate DICOM RTSS file.
SNOMED-CT “Anatomic Region Sequence” and “Segmented Property Category Code Sequence” and codes were inserted for all segmented structures.
Imaging time point codes were inserted to help identify each annotation in the context of the clinical trial assessment protocol.
(255235001, SCT, “Pre-dose”)
(262502001, SCT, "Post-chemotherapy") #1
(262502001, SCT, "Post-chemotherapy") #2
(262061000, SCT, "Post-operative")
(262502001, SCT, "Post-chemotherapy") #3
(262502001, SCT, "Post-chemotherapy") #4
“Clinical Trial Time Point ID” was used to encode time point type using one of the following strings as applicable: “pre-dose”, “post-chemotherapy”, or “post-operative”.
Content Item in “Acquisition Context Sequence” was added containing "Time Point Type" using Concept Code Sequence (0040,A168) selected from:

本数据集源自美国国家癌症研究所（National Cancer Institute, NCI）临床试验《肾母细胞瘤（Wilms Tumor）儿童患者联合化疗与手术治疗研究（AREN0534）》的影像标注数据。本项目的核心目标是构建大规模且经过严格质控的儿童肾母细胞瘤患者影像数据集，生成适配癌症研究者与AI开发者的标准化标注信息。

### 标注规范
针对每一位患者，研究人员将审阅其所有DICOM（数字成像和通信医学，Digital Imaging and Communications in Medicine）检查与DICOM序列，以识别并标注临床相关的时间节点与影像序列。典型患者的标注时间节点包括：
1. 术前胸部CT及腹部CT/磁共振成像（Magnetic Resonance Imaging, MRI）
2. 术后6周的胸部CT及/或腹部CT/MRI
3. 疑似术后12周的腹部CT/MRI
对于12周之后的影像：若为阴性结果，则标注为阴性；若12周后影像显示肿瘤阳性，则以最后一次阳性检查结果作为标注依据。

#### 典型患者标注规则
本研究针对典型患者遵循以下标注规则：
1. 原发肾肿瘤需在增强轴位序列上进行标注，正常肾实质需排除在外。
2. 单次扫描（单一时间节点）最多标注5个病灶，且每个器官最多标注2个病灶；同一时间节点下需保持相同的5个病灶标注。病灶标注遵循实体瘤疗效评价标准1.1版（Response Evaluation Criteria in Solid Tumors 1.1, RECIST 1.1）原则：若存在不足5个直径大于1cm的病灶，则可标注更小的病灶，仍需遵循每个器官最多2个、单次扫描最多5个的限制。若无其他病灶，则可纳入骨病灶。
3. 所有病灶需单独标注。
4. 种子点（Seed points）由算法自动生成，但需经放射科医师审核确认。

#### 单时间节点标注流程
在每个时间节点下：
1. 为每个分割结构生成种子点（核），各分割对应的种子点将单独存储于DICOM放射治疗结构集（DICOM RT Structure Set, RTSS）文件中。
2. 为所有分割结构插入医学系统命名法-临床术语（Systematized Nomenclature of Medicine -- Clinical Terms, SNOMED-CT）的“解剖区域序列”与“分割属性类别代码序列”及对应代码。
3. 插入影像时间节点代码，以匹配临床试验评估协议的上下文，便于识别每一条标注信息，具体代码如下：
(255235001, SCT, "给药前")
(262502001, SCT, "化疗后") #1
(262502001, SCT, "化疗后") #2
(262061000, SCT, "术后")
(262502001, SCT, "化疗后") #3
(262502001, SCT, "化疗后") #4
4. 使用"临床试验时间节点ID"字段，通过以下适用字符串编码时间节点类型："给药前"、"化疗后"或"术后"。
5. 在"采集上下文序列"的内容项中，通过选自以下范围的概念代码序列（0040,A168）添加"时间节点类型"信息。