NCT04695938

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Cambridge · Academic / Other
• Sex: All
• Age: 0 Months – 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Craniosynostoses
• Synostosis
• Skull Deformity

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI	MRI examination with Black Bone, and ultrashort/zero echo time MRI techniques

Timeline

• Start date: 2020-11-27
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2021-01-05
• Last updated: 2021-01-05

Locations

1 site across 1 country: United Kingdom