A Retrospective Single-Center Study Utilizing AI-Based Radiomics on Pre- and Post-Radiotherapy CT Images to Explore the Safety Dose Threshold in Liver Malignancy Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Dose Threshold for Focal Liver Reaction (FLR)
研究概览
简要总结
The goal of this retrospective observational study is to investigate the safety of radiation therapy for liver malignancies by analyzing data from patients who have already completed this treatment . The main questions it aims to answer are:
What is the specific radiation dose level that leads to a visible change on CT scans called a Focal Liver Reaction (FLR)? Why do some patients develop these imaging changes while others do not, based on their scan features and clinical information? Researchers will compare patients who developed FLR with those who did not to identify the factors associated with this reaction.
This study uses existing medical records and images; therefore, participants will not need to undergo any new interventions or procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or secondary liver malignancies, including hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), and secondary liver tumors.
- •Liver function of Child-Pugh classification A or B.
- •Completed EBRT treatment as planned.
- •No other local treatment of liver lesions between EBRT and the follow-up imaging examination.
- •Complete imaging re-examination data.
- •Three-phase enhancement CT scans showing typical Focal Liver Reaction (FLR).
- •The registration effect of follow-up CT and planning CT is satisfactory.
排除标准
- •History of upper abdominal radiotherapy or liver transplantation.
- •Failure to complete radiotherapy as scheduled.
- •Previous cancer treatment-related toxicities that did not return to baseline or grade 0-1 (except for hair loss and peripheral neuropathy).
研究组 & 干预措施
FLR Group
Patients who developed Focal Liver Reaction (FLR) on follow-up CT imaging after radiotherapy
干预措施: Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer (Other)
Non-FLR Group
Patients who did not develop Focal Liver Reaction (FLR) on follow-up CT imaging after radiotherapy
干预措施: Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer (Other)
结局指标
主要结局
Dose Threshold for Focal Liver Reaction (FLR)
时间窗: Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapy
The minimum radiation dose (in Gy) required to induce a radiologically visible Focal Liver Reaction (FLR) on follow-up CT imaging, as assessed by CT scan.
Predictors of FLR Susceptibility
时间窗: Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapy
Differences in radiomic features and clinical baseline characteristics (e.g., age, gender, liver function, and tumor size) between patients with radiologically confirmed Focal Liver Reaction (FLR) and those without, assessed by radiomic analysis and clinical data review.
次要结局
未报告次要终点
研究者
Cao peiguo
Professor peiguo Cao, Chief Physician of Radiation Oncology Department, the Third Xiangya Hospital
The Third Xiangya Hospital of Central South University