A Single-Center, Prospective Study Comparing the Diagnostic Efficiencies of Contrast-Enhanced Ultrasound and EOB Contrast-Enhanced Magnetic Resonance Imaging for Lesions With Diameters ≤ 2cm in Patients With High Risk of HCC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- The sensitivity, specificity and accuracy of CEUS and EOB-MRI
研究概览
简要总结
HCC is a serious threat to the health of people. Accurate diagnosis of early HCC by imaging allows patients to obtain proper treatment. However, for lesions with diameters ≤2 cm, the tumor blood supply is not fully established, and there may be no typical manifestation on the image. In addition, atypical enhanced patterns caused by liver cirrhosis may also hinder imaging diagnosis of HCC. Therefore, early diagnosis of HCC in the context of cirrhosis remains a major clinical problem.
Contrast-enhanced Ultrasound (CEUS) and MRI Contrast-enhanced Magnetic Resonance Imaging (CEMRI) are common diagnostic imaging methods. Till now, there is still lack of a detailed investigation comparing the diagnostic efficacies of CEUS and EOB-MRI for micro HCC in the context of cirrhosis. Therefore, this study aims to analyze the imaging patterns in CEUS and EOB-MRI for liver lesions with diameters ≤ 2 cm among patients with high risk of HCC, and to compare the diagnostic efficacies of EOB-MRI and CEUS for early-stage HCCs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are at high risk of HCC.
- •The ages of patients are between 18 and
- •Patients are with solid liver lesion(s) ≤ 2 cm detected by imaging scan (US/CT/MRI).
- •The number of lesions is less than or equal to
- •Patient is able and willing to receive CEUS and EOB-MRI examinations within 30 days.
- •Patient signs the informed consent.
排除标准
- •Patient is with lesions confirmed by pathology or follow-up, or hemangiomas.
- •Patient is with lesions already undergoing local treatment, including thermal ablation or TACE.
- •Patient is with severe cardiopulmonary insufficiency.
- •Patient is a pregnant or breastfeeding women.
- •Patient is considered to be unsuitable to participate in the study.
结局指标
主要结局
The sensitivity, specificity and accuracy of CEUS and EOB-MRI
时间窗: 6 to 12 months
The sensitivity, specificity and accuracy of CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.
次要结局
- The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI(6 to 12 months)