跳至主要内容
临床试验/NCT04695938
NCT04695938Unknown不适用

Craniofacial Imaging With 3D MRI: an Alternative to Ionising Radiation

University of Cambridge2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年11月27日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Karen A Eley

Clinical Lecturer in Radiology

University of Cambridge

研究点 (2)

Loading locations...

相似试验

Craniofacial Imaging With 3D MRI: an Alternative to... | 临床试验