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

University of Cambridge

Status: Unknown

Conditions: Skull Deformity; Craniosynostoses; Synostosis

Treatments: Diagnostic Test: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT04695938

18/WA/0155

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children in whom craniosynostosis is clinically suspected

Exclusion criteria

• Children with contraindications to MRI examination
• Children who require sedation/anaesthesia solely for the purpose of research MRI

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

MRI

Other group

Description:

MRI examination

Treatment:

Diagnostic Test: MRI