Characterization of Liver Masses With Contrast Enhanced Ultrasound (CEUS): A Comparison With Standard Institutional Contrast Enhanced CT (CECT) or MR Scan (CEMRI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.
研究概览
简要总结
This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose noninvasively focal liver masses. This is a multi-center prospective cohort study of 250 subjects, which will be performed at four institutions in Canada. Subjects with a focal liver mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed on standard ultrasound scanners with contrast specific imaging capability. The contrast agent used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the standard of care in the institution. Anonymized image files from all imaging will be shown independently to two readers, blinded to all clinical and demographic data, who will predict malignancy and diagnosis.
详细描述
This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose noninvasively focal liver masses. This is a multi-center prospective cohort study of 250 subjects, which will be performed at four institutions in Canada. Subjects with a focal liver mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed on standard ultrasound scanners with contrast specific imaging capability. The contrast agent used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the standard of care in the institution. Anonymized image files from all imaging will be shown independently to two readers, blinded to all clinical and demographic data, who will predict malignancy and diagnosis.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An incidental liver mass amenable to US evaluation
- •Undiagnosed liver mass
- •Mass threshold size is 2.5 cm
- •Source of subjects:
- •Liver mass found on conventional institutional US
- •Liver mass detected on CT and MRI that remain uncategorized
- •Referral of patient with a liver mass following detection in outside institution.
- •Confirmatory CT or MRI performed within 60 days of initial scan according to the institutional protocols
排除标准
- •Any known pre existing mass
- •Pregnancy
- •Severe or unstable cardiac disease, including angina, congestive heart failure, or arrhythmias
- •Severe COPD
- •Pulmonary hypertension
- •Bidirectional shunts
- •Transient right to left shunts
- •Known hypersensitivity to Definity or any of its components
结局指标
主要结局
Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.
时间窗: 6-9 months
次要结局
- Diagnosis of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.(6-9 months)
研究者
Stephanie R Wilson, MD
Clinical Professor University of Calgary
Foothills Medical Centre