Magnetic Resonance With Gadoxetic Acid for the Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis. Evaluation of Its Impact for the Non-invasive Diagnosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- hepatocellular carcinoma diagnosed
研究概览
简要总结
This is a study to evaluate the primovist as a new contrast agent useful to diagnostic of hepatocellular carcinoma
详细描述
The investigators plan to define the imaging patterns of hepatocellular carcinoma in cirrhotic patients when studied with gadoxetic acid magnetic resonance imaging including the dynamic phase and the hepatobiliary phase at 10 and 20 minutes after contrast injection and to evaluate the usefulness of liver magnetic resonance imaging with gadoxetic acid in the differentiation between benign and malignant nodules in the cirrhotic liver. To determine the diagnosis and clinical significance of the infracentimetric additional nodules detected in the hepatobiliary phase
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
- •more than 18 years old
- •patient with diagnosis of liver cirrhosis Child Pugh A-B
- •Patients without previous hepatocellular carcinoma in whom ultrasound detects a suspicious hepatic lesion; solitary solid and well-defined nodule between 10 and 20mm
- •patients in whom diagnosis of hepatocellular carcinoma is a clinical need prior to treatment indication
- •patient that agree to participate signing informed consent form
排除标准
- •Patients with poor liver function who would have undergone transplantation even without hepatocellular carcinoma diagnosis (Child-Pugh C)
- •patients with previous diagnosis of hepatocellular carcinoma
- •patients with significant comorbidities that could prevent the optimum therapeutic decision in case of positive diagnosis of hepatocellular carcinoma
- •patients with severe clotting alterations that contraindicate the fine-needle biopsy -Patients with chronic kidney disease or glomerular filtration rate < 30 ml/min
- •patients with contraindications to perform magnetic resonance imaging (pacemaker, claustrophobia...)
- •Known hypersensitivity to study drugs or excipients
- •pregnancy or breastfeeding
研究组 & 干预措施
GADOXETIC ACID
Is a non comparative study. a magnetic resonance will be done using gadoxetic acid : 0.025mmol/Kg
干预措施: GADOXETIC ACID (Drug)
结局指标
主要结局
hepatocellular carcinoma diagnosed
时间窗: 1 month
Proportion of hepatocellular carcinoma diagnosed using gadoxetic acid magnetic resonance imaging (accuracy for diagnosis)
次要结局
- magnetic resonance imaging sensitivity(9 months)
研究者
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica