Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Pulmonary blood flow
研究概览
简要总结
The primary objective of this study is to determine if quantitative Dynamic contrast-enhanced magnetic resonance (DCE MR) perfusion imaging accurately quantifies right and left pulmonary artery blood flow as compared with phase contrast flow velocity mapping (PC), the current gold standard of flow volume measurements.
详细描述
Many conditions of the heart or the lungs lead to differences in how the blood is pumped to the lungs. Specifically, some areas of the lung may receive less blood supply than others. We would like to do a research study in children and adolescents who have a heart condition or a chronic or stable lung condition. We are doing this study to see if measuring the circulation of blood in the lungs in children is possible using magnetic resonance imaging (MRI) with a special dye (contrast medium) injection called Magnevist®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac Patients:
- •Patients > 6 years of age
- •Patients with suspected or confirmed congenital or acquired heart disease
- •Who undergo a clinically indicated MRI scan, including gadolinium (MRI contrast medium)
- •And receive gadolinium (= MRI contrast medium) as part of their clinical investigation
- •Pulmonary Patients:
- •Patients > 6 years of age
- •Patients with a chronic and stable lung condition, such as cystic fibrosis, severe asthma.
排除标准
- •Children under the age of 6 will be excluded as they are routinely scanned under general anesthesia
- •Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos)
- •Patients with a known allergy to gadolinium.
- •Patients with a history of allergic disposition or have anaphylactic reactions
- •Moderate-to-severe renal impairment (defined as having a GFR/ eGFR < 60 mL/min)
- •Have Sickle Cell anemia
- •Known pregnancy, or breast feeding
- •Patient is uncooperative during a MRI without sedation or anesthesia
结局指标
主要结局
Pulmonary blood flow
时间窗: 1 hour
Pulmonary blood flow as measured with DCE MRI perfusion imaging will be compared to MRI phase contrast imaging, which is the gold standard of non-invasive flow measurements.
次要结局
- Perfusion defects detected(1 hour)
- Quantitative results from dynamic contrast-enhanced magnetic resonance perfusion imaging(1 hour)
研究者
Lars Grosse-Wortmann
Principal Investigator
The Hospital for Sick Children