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Clinical Trials/NCT04695938
NCT04695938
Unknown
Not Applicable

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

University of Cambridge1 site in 1 country80 target enrollmentNovember 27, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Craniosynostoses
Sponsor
University of Cambridge
Enrollment
80
Locations
1
Primary Endpoint
Diagnosis of craniosynostosis
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 27, 2020
End Date
July 31, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Karen A Eley

Clinical Lecturer in Radiology

University of Cambridge

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

Outcomes

Primary Outcomes

Diagnosis of craniosynostosis

Time Frame: 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

Time Frame: 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

Study Sites (1)

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