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
- 1
- 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
研究组 & 干预措施
Cardiac Patients
In addition to the routine clinical MRI, we will conduct the DCE MR perfusion imaging research component. For this, we will measure native pre-contrast T1 and then inject a tight bolus of gadolinium (0.1mmol/kg) while acquiring high temporal resolution T1-weighted 3D contrast dynamics information over the whole thorax while the patient is holding his / her breath. Overall, the research component will prolong the clinical study by approximately 5 minutes.
干预措施: Phase contrast flow velocity mapping (PC) (Procedure)
Cardiac Patients
In addition to the routine clinical MRI, we will conduct the DCE MR perfusion imaging research component. For this, we will measure native pre-contrast T1 and then inject a tight bolus of gadolinium (0.1mmol/kg) while acquiring high temporal resolution T1-weighted 3D contrast dynamics information over the whole thorax while the patient is holding his / her breath. Overall, the research component will prolong the clinical study by approximately 5 minutes.
干预措施: Dynamic contrast-enhanced magnetic resonance imaging (Procedure)
Pulmonary Patients
Patients in this group will receive a full cardiac and pulmonary MRI assessment, with the DCE pulmonary perfusion scan added as described above. Overall, the investigation will take approximately 45 minutes
干预措施: Phase contrast flow velocity mapping (PC) (Procedure)
Pulmonary Patients
Patients in this group will receive a full cardiac and pulmonary MRI assessment, with the DCE pulmonary perfusion scan added as described above. Overall, the investigation will take approximately 45 minutes
干预措施: Dynamic contrast-enhanced magnetic resonance imaging (Procedure)
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