The Performance of Spectral CT in Evaluating Treatment Response After Transarterial Chemoembolization for Hepatocellular Carcinoma: The SpecTRAIL Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of spectral CT in identifying nonviable HCC lesions.
研究概览
简要总结
By comparing the diagnostic accuracy of spectral CT and conventional CT in evaluating treatment response efficacy after TACE, this study aims to investigate the diagnostic performance of spectral CT in assessing treatment response following TACE for hepatocellular carcinoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-75 years;
- •diagnosis of HCC based on pathological findings or accepted clinical and imaging criteria;
- •Barcelona Clinic Liver Cancer (BCLC) stage A or B;
- •prior treatment with TACE;
- •undergoing contrast-enhanced spectral CT at 4-8 weeks after TACE;
- •undergoing either liver resection within 1 week after contrast-enhanced spectral CT (surgical cohort) or undergoing hepatic digital subtraction angiography (DSA) or contrast-enhanced MRI within 1 week after contrast-enhanced spectral CT (non-surgical cohort);
- •informed consent.
排除标准
- •contraindications to contrast-enhanced CT or MRI;
- •presence of extrahepatic malignancy;
- •poor image quality or incomplete clinical data;
- •lack of regular CT or MRI follow-up in non-surgical cohort;
- •withdrawal from the study.
结局指标
主要结局
Diagnostic accuracy of spectral CT in identifying nonviable HCC lesions.
时间窗: From enrollment to the completion of the 1-year follow-up
Two or more investigators independently evaluated the multiparametric spectral CT images of the patients using the mRECIST criteria. The imaging assessment results were recorded as CR, PR, PD, or SD. First, the agreement between spectral CT-based assessments and those obtained from conventional clinical CT was evaluated. Subsequently, the spectral CT imaging results were compared with the reference standard to assess the diagnostic accuracy of spectral CT.
Diagnostic Performance of Spectral CT for Residual Viable Hepatocellular Carcinoma After TACE.
时间窗: From enrollment to the completion of the 1-year follow-up.
Imaging Assessment Criteria: For target lesions, imaging evaluation was performed using the mRECIST and LI-RADS TRA v2024 criteria, with histopathological findings serving as the reference standard. Imaging Assessment Procedure: Two or more investigators independently and blindly reviewed the multiparametric spectral CT images of the patients. Lesions were assessed using the mRECIST criteria. The imaging assessment results were recorded as CR, PR, PD, or SD. The imaging findings were compared with the pathological reference standard to assess the diagnostic performance of spectral CT.
次要结局
未报告次要终点
研究者
Yuan-Cheng Wang
Head of Radiology
Zhongda Hospital