Assessment of Liver Cancer Response to Transcatheter Arterial Chemoembolization (TACE) Using Functional Triple-Phase MultiHance-Enhanced Magnetic Resonance Imaging (MRI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Nodule Size
研究概览
简要总结
This research is being done to find out if using the contrast agent MultiHance can be used to show how a liver tumor responds to the chemotherapy given during Transcatheter Arterial Chemoembolization (TACE).
详细描述
MultiHance is approved by the Food and Drug Administration (FDA) for use as a contrast material for Magnetic Resonance Imaging (MRI) scans of the central nervous system. It is believed that using MultiHance may be able to help doctors tell normal liver cells apart from active tumor and from tumor affected by the chemotherapy. In this way, MultiHance may improve the way patients with hepatocellular carcinoma are managed clinically.
We hypothesize that the Multi-Hance contrast material will provide better image definition of treated liver tumor(s) on MRI imaging in comparison to other commercially available contrast agents.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients between the ages of 18 - 80 seen in the cardiovascular and interventional radiology clinic who are scheduled for TACE.
- •International Normalized Ratio (INR) <1.4
- •Platelet count > 80,000
排除标准
- •Contraindications to TACE procedure
- •Unable to have an MRI Scan
- •Allergy or hypersensitivity reactions to gadolinium or any other ingredients, including benzyl alcohol
- •Patients with sickle cell anemia , hemoglobinopathies and other hemolytic anemias
- •Known clinical hypersensitivity or a history of asthma or allergic respiratory disorders
- •Patients with advanced renal failure (those currently requiring dialysis or with a Glomerular Filtration Rate<15cc/min)
- •Pregnancy
研究组 & 干预措施
Gadobenate Dimeglumine (Multi Hance)
If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study
干预措施: gadobenate dimeglumine (MultiHance) (Drug)
结局指标
主要结局
Nodule Size
时间窗: 3 months
Maximal nodule size measured in centimeters
Nodule Enhancement
时间窗: 3 month
Percent area of nodule with enhancement
次要结局
未报告次要终点