Clinical Study of MRI Assessment of Iron in the Myocardium, Liver, Pancreas and Pituitary Gland in Patients With High Transfusion Dependence on the Packed Red Blood Cells
试验速览
- 阶段
- 不适用
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Compare and contrast T2* values in pancreas, myocardium, and pituitary gland in patients with transfusion-dependent anemia using 1.5T and 3T MRI scanner.
研究概览
简要总结
All patients were investigated using a 3T MRI and 1,5 T MRI scanners. For myocardium, pancreas and pituitary gland iron overload quantification in children we have used special sequences for T2*-mapping.
Miocardium, pancreas and pituitary gland T2* relaxometry maps were calculated automatically by commertial application ReportCARD Functool (GE Healthcare) and integrated Philips T2* maps. Then for selected ROI T2* data acquisition in milisecond [ms] were performed and calculated automatically.
详细描述
All patients were investigated using a 3T MRI scanner (Philips Achieva) and 1,5 T MRI scanner (GE Signa) with 8-channel surface coil for body scanning. For myocardium, pancreas and pituitary gland iron overload quantification in children we have used special sequences for T2*-mapping based on fast gradient echo sequences - multi-phase fast gradient echo and ultrashort gradient echo (uTE) in axial and coronary plane. For breath-hold acquisition due to failure of communication and invariable behavior some children received anaesthetic support with mechanical ventilation. Miocardium, pancreas and pituitary gland T2* relaxometry maps were calculated automatically by commertial application ReportCARD Functool (GE Healthcare) and integrated Philips T2* maps.
The placement of region of interest (ROI) in target organ were performed by following criterion: for the myocardium - in the interventricular septum in short axis plane; for the pancreas - in corpus in axial plane; for the pituitary gland - in adenohypophysis; for all organs the area of large and small blood vessels, which can introduce distortions of the obtained results were excluded. Then for selected ROI T2* data acquisition in milisecond [ms] were performed and calculated automatically by approximating the attenuation curve with the highest likelihood method.
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
- 6 Years 至 25 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Compare and contrast T2* values in pancreas, myocardium, and pituitary gland in patients with transfusion-dependent anemia using 1.5T and 3T MRI scanner.
时间窗: up to 1 week after the end of chelation therapy
次要结局
- To calculate the T2* values in the pancreas, myocardium and pituitary gland in patients with transfusion-dependent anemia on the 3T scanner.(point1: Initially, after one month of chelation therapy; point 2: every week during 1 month for the stability checking point 3: ut to 1 week at the end of the study)
- To develop a control method for iron assessment using aqueous solutions of iron nanoparticles by calculating T2* values on 3T and 1,5T scanners.(point1: Initially, after one month of chelation therapy; point 2: every week during 1 month for the stability checking point 3: ut to 1 week at the end of the study)
- Draw up T2* values recalculating tables for a 3T scanner based on the distribution of T2* values for a 1.5T scanner in pancreas, myocardium, and pituitary gland in patients with transfusion-dependent anemia.(point1: Initially, after one month of chelation therapy; point 2: every week during 1 month for the stability checking point 3: ut to 1 week at the end of the study)
