MR Techniques in the Evaluation of Hepatocellular Carcinoma: Gadoxetate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Precision in tumor measurement for each type of image (CT vs. MRI), for each phase ( 4 for CT and 5 for MRI), and for each method of measuring "size" (1-,2-, and 3-dimensional), assessed by low inter- and intra-reader variability
研究概览
简要总结
This pilot clinical trial studies magnetic resonance imaging (MRI) with gadoxetate disodium in measuring tumors in patients with liver cancer. Diagnostic procedures, such as MRI with gadoxetate disodium, may help find and diagnose liver cancer and find out how far the disease has spread. It is not yet known whether MRI with gadoxetate disodium provides a more precise measurement of liver tumors than standard computed tomography (CT).
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the precision of gadoxetate (gadoxetate disodium)-enhanced MRI in evaluating lesion size.
II. To evaluate if there is a subjective improvement in the delineation of hepatocellular carcinoma (HCC) in the hepatocellular phase of contrast administration.
III. To further assess the sensitivity of gadoxetate-enhanced MRI for the detection of HCC.
SECONDARY OBJECTIVES:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CT features suggestive of HCC, including those features which have been described herein; they are also enumerated below:
- •For an arterially-enhancing lesion greater than or equal to 1 cm, but under 2 cm, all of the following criteria must be met:
- •Imaging features of a mass
- •Wash-out on later phases of contrast administration
- •At least 1 cm or more growth
- •For an arterially-enhancing lesion greater than or equal to 2 cm, two of the following criteria must be met:
- •Imaging features of a mass
- •Wash-out on later phases of contrast administration
- •At least 1 cm or more growth
- •All enhancing lesions with expansile, solid, enhancing tumor within vascular structures will be included, including the main portal vein, the main right and main left portal veins, the inferior vena cava (IVC), and the main hepatic veins
- •No prior history of treatment of liver lesions
- •Able to provide written and verbal informed consent
- •Able to tolerate a complete abdominal MR examination, within 3 weeks of CT
排除标准
- •Unable to provide written and verbal informed consent
- •Unable to undergo MRI due to intraocular metallic foreign body, pacemaker, or other contraindications including objects in the body which are deemed to be unsafe or notable to be assessed, or unable to undergo MRI within 3 weeks of CT
- •Pregnancy
- •Severe renal insufficiency as defined by an estimated glomerular filtration rate of less than 30 cc/minute
- •Severe liver disease as defined by Childs class C cirrhosis
- •History of a previous reaction to contrast media
- •History of bronchial asthma
- •History of allergic disorders
- •Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period
研究组 & 干预措施
Diagnostic (gadoxetate disodium MRI)
Patients receive gadoxetate disodium IV and then undergo enhanced liver MRI.
干预措施: Gadoxetate Disodium (Drug)
Diagnostic (gadoxetate disodium MRI)
Patients receive gadoxetate disodium IV and then undergo enhanced liver MRI.
干预措施: Magnetic Resonance Imaging (Device)
结局指标
主要结局
Precision in tumor measurement for each type of image (CT vs. MRI), for each phase ( 4 for CT and 5 for MRI), and for each method of measuring "size" (1-,2-, and 3-dimensional), assessed by low inter- and intra-reader variability
时间窗: Up to 24 hours
Initially, a random effects analysis of variance (ANOVA) will be performed for each type of image (CT vs. MRI), for each phase (4 for CT and 5 for MRI) and for each method of measuring "size" (1-, 2-, and 3-dimensional) - for a total of 27 ANOVAs. Lesion, radiologist, and replication (for the 20 target lesions measured twice) will all be random effects; the inter-reader and the intra-reader variability will be estimated from these models and 95% confidence intervals will be constructed.
次要结局
- Changes in apparent diffusion coefficient (ADC) values within lesions and within normal liver before and after administration of Gadoxetate(Up to 24 hours)