Prospective Evaluation of Local Tumor Progression After Radiofrequency Ablation of Hepatocellular Carcinoma: Effectiveness of Immediate Second-Look Evaluation Using Pre-RFA MRI and Post-RFA CT Registration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Local tumor progression (LTP)
研究概览
简要总结
Magnetic resonance imaging (MRI) has been widely used for small liver lesion detection and characterization. In patients who undergo RFA, MRI is often performed before RFA, whereas immediate technical success is usually assessed by CT. Conventional visual assessment of two modalities may be more challenging than being anticipated, because acquisition position, respiration, and spatial resolution differ between the two. Therefore, the study purpose is to evaluate the results of software-assisted ablative margin assessment using registration of different pre-and post-RFA modalities compared with the conventional method of side-by-side MRI-CT comparison in patients with HCCs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients (≥ 18 years) who were referred to our radiology department for liver tumor RFA
- •patients who had liver MR images of sufficient quality for pre-RFA evaluation within 30 days before RFA
- •patients with 1-3 tumors (<5 cm)
排除标准
- •Child-Pugh class C
- •any uncorrected coagulopathy
- •hypersensitivity to iodine or other reasons that prevented the performance of post-RFA contrast-enhanced CT
结局指标
主要结局
Local tumor progression (LTP)
时间窗: 60 months
5-year-LTP rate in HCC between sufficient and insufficient ablative margin groups (according to visual assessment and registration software-assisted assessment)
次要结局
- technique efficacy(1 month after RFA)
- immediate technical success on visual assessment(1 day after RFA)
- immediate technical success on registration-software assessment(1 day after RFA)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital