Craniofacial Imaging With 3D MRI: an Alternative to Ionising Radiation
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Diagnosis of craniosynostosis
研究概览
简要总结
Craniosynostosis is a condition where infants are born with or subsequently develop an abnormally shaped skull. The skull develops from plates of bone separated from each other by growth lines (sutures). Craniosynostosis refers to early fusion of one or more of these sutures.
Whilst in many cases the abnormal head shape provides doctors with the underlying diagnosis, it is necessary to confirm this using imaging. A CT scan involves using multiple x-rays to build a picture of the part of the body being examined. X-rays are associated with potential long term harm, particularly in young children who have longer to incur those risks. MRI uses magnets and radiowaves to create images of the body, and therefore a radiation-free method of imaging.
The investigators have previously shown in a pilot group that a specific MRI technique ("Black Bone") can distinguish between normal and prematurely fused cranial sutures, and that the images can be reconstructed in 3D in the same way as CT.
The investigators now need to confirm the findings in a larger patient group, and develop automated methods of creating 3D images of the bone.
Children in whom there is clinical suspicion of craniosynostosis will be recruited for MRI examination. In children who are already undergoing MRI examination of the head (for any indication), the investigators will add on bone specific sequences.
There are no known long term risks associated with MRI, and no contrast medium is required. Anonymised MRI data will be used to further develop our 3D techniques.
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
- 0 Months 至 2 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children in whom craniosynostosis is clinically suspected
排除标准
- •Children with contraindications to MRI examination
- •Children who require sedation/anaesthesia solely for the purpose of research MRI
结局指标
主要结局
Diagnosis of craniosynostosis
时间窗: Average one week for diagnosis of individual participants. End of study (2 years) for cohort analysis.
Accuracy of diagnosis on MRI of craniosynostosis
3D reconstruction of craniofacial MRI
时间窗: Preliminary 3D outputs within 2 weeks of participation per patient, and by end of study for automated segmentation algorithms(2 years)
Automated segmentation of craniofacial MRI
次要结局
未报告次要终点
研究者
Dr Karen A Eley
Clinical Lecturer in Radiology
University of Cambridge
