Clinical trial NCT04695938: Craniofacial Imaging With 3D MRI: an Alternative to Ionising Radiation
Official title: Craniofacial Imaging With 3D MRI: an Alternative to Ionising Radiation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Craniosynostoses
Synostosis
Skull Deformity
Keywords: Image Reconstruction
Medical Imaging
Magnetic Resonance Imaging
Imaging, Three-Dimensional
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: Great Ormond Street Hospital for Children NHS Foundation Trust
name: Oxford University Hospitals NHS Trust
name: Cambridge University Hospitals NHS Foundation Trust
First posted: 2021-01-05
Enrollment: 80
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of craniosynostosis
timeFrame: Average one week for diagnosis of individual participants. End of study (2 years) for cohort analysis.
measure: 3D reconstruction of craniofacial MRI
timeFrame: Preliminary 3D outputs within 2 weeks of participation per patient, and by end of study for automated segmentation algorithms(2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: University of Cambridge
Study officials:
References: