Abbreviated MRI (AMRI) vs. Ultrasound for HCC Surveillance in Cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection
研究概览
简要总结
This study compares gadolinium contrast-enhanced Abbreviated MRI (AMRI) to standard ultrasound for Hepatocellular Carcinoma (HCC) screening and surveillance in subjects with liver cirrhosis.
详细描述
Ultrasound (US) is currently used for HCC surveillance. However, US has certain limitations, so physicians use contrast CT or MRI. However, these are expensive and time-consuming procedures. We introduced an abbreviated MRI (AMRI) exam, which works well in cirrhotic and obese patients (unlike US), involves no ionizing radiation (unlike CT), and is rapid (unlike multi-phasic MRI) with total scanner times of less than ten minutes, and can be performed at about the same cost as US. This study in adult patients with cirrhosis will compare the performance of AMRI vs. US for detection of early-stage disease, and will help to define and validate a novel, rapid, accurate, and potentially cost-effective imaging protocol for HCC screening in high-risk individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents.
- •Adult subjects of any gender and any ethnic group with liver cirrhosis of any etiology,
- •Subject is able and willing to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, lab collection if needed, research AMRI exam, research US exam) and the three optional surveys (if subject opts in for that) within specified time windows, and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images.
排除标准
- •VA patient
- •< 18 years of age
- •History of any liver cancer
- •MRI contraindication(s)
- •Subject knows that she is pregnant or states she trying to become pregnant
- •Positive urine pregnancy test in woman of childbearing potential
- •Nursing mother
- •Subject has known allergy to any gadolinium agent
- •Does not meet UC San Diego Intravenous Contrast Media Guidelines for administration of Eovist*
- •Clinical screening exam of the liver performed at UCSD within the prior 90 days to consent
研究组 & 干预措施
Single arm
This is a single arm study in which all participants have one ultrasound and one abbreviated MR exam
干预措施: Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid (Drug)
结局指标
主要结局
Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection
时间窗: up to one year
per-patient sensitivity, specificity, positive predictive (PPV), negative predictive value (NPV) and accuracy of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening
Reader reliability of screening modalities
时间窗: up to 12 months from completion of imaging
the inter- and intra-reader reliability of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening
次要结局
未报告次要终点
研究者
Claude Sirlin
Professor
University of California, San Diego