Lesion Detection in Cirrhotic Patients With Contrast Enhanced Ultrasound and the Accuracy of Contrast Enhanced Ultrasound Li-RADS for Hepatocellular Carcinoma Diagnosis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Accuracy of contrast enhanced ultrasound (CEUS) with contrast agent sulfur hexafluoride lipid-type A microspheres and B-mode non-contrast enhanced ultrasound
研究概览
简要总结
This early phase I trial studies how well contrast enhanced ultrasound with sulfur hexafluoride lipid microspheres (Lumason) works in detecting liver cancer in participants with cirrhosis. Contrast enhanced-ultrasounds use contrast agents, such as Lumason, that are injected into a vein in order to help certain organs and tissues show up more clearly on scans. Contrast enhanced ultrasound with Lumason may help doctors more easily find liver cancer compared to ultrasounds without contrast agent.
详细描述
PRIMARY OBJECTIVES:
I. Determine the accuracy of contrast enhanced ultrasound (CEUS) utilizing contrast agent sulfur hexafluoride lipid-type A microspheres compared to B-mode non-contrast enhanced ultrasound for liver lesion detection, including hepatocellular carcinoma (HCC), in cirrhotic ultrasound (US) patients.
SECONDARY OBJECTIVES:
I. Determine the concordance of CEUS vs. contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads).
OUTLINE:
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
- •Able and willing to provide written informed consent
- •Diagnosis of cirrhosis based on one or more of the following: histology, US, computed tomography (CT) or MRI showing cirrhosis, +/- lesions seen on CE-MRI
排除标准
- •History of hypersensitivity to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason
- •Pregnant patients-excluded by history
- •Pediatric patients, as pediatric cirrhosis is uncommon
研究组 & 干预措施
Screening (US, CEUS, Lumason)
Within 30 days of routine MRI, participants undergo non-contrast ultrasound of the abdomen. Participants then receive Lumason IV and undergo contrast-enhanced ultrasound of the abdomen over 1 hour in the absence of disease progression or unacceptable toxicity.
干预措施: Contrast-Enhanced Ultrasound (Procedure)
Screening (US, CEUS, Lumason)
Within 30 days of routine MRI, participants undergo non-contrast ultrasound of the abdomen. Participants then receive Lumason IV and undergo contrast-enhanced ultrasound of the abdomen over 1 hour in the absence of disease progression or unacceptable toxicity.
干预措施: Sulfur Hexafluoride Lipid Microspheres (Drug)
Screening (US, CEUS, Lumason)
Within 30 days of routine MRI, participants undergo non-contrast ultrasound of the abdomen. Participants then receive Lumason IV and undergo contrast-enhanced ultrasound of the abdomen over 1 hour in the absence of disease progression or unacceptable toxicity.
干预措施: Ultrasound (Procedure)
结局指标
主要结局
Accuracy of contrast enhanced ultrasound (CEUS) with contrast agent sulfur hexafluoride lipid-type A microspheres and B-mode non-contrast enhanced ultrasound
时间窗: Up to 3 years
The study will estimate the sensitivity of ultrasound (US) and CEUS in patients with detectable lesions on magnetic resonance imaging (MRI). The analysis will be conducted at the patient level with a binary outcome of 0 if the patient has no detectable lesions and 1 if the patient has one or more detectable lesions. The study will use McNemar's test to compare US vs. CEUS in patients with any detectable lesions on MRI. The test assesses whether the two tests have equivalent marginal probabilities (i.e. probability of detecting at least one lesion with US and CEUS is equivalent). McNemar's test statistic depends only on patients where US and CEUS disagree.
次要结局
- Assessment of CEUS and contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads)(Up to 3 years)