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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04695938
Enrollment
80
Registered
2021-01-05
Start date
2020-11-27
Completion date
2023-07-31
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniosynostoses, Skull Deformity, Synostosis

Keywords

Image Reconstruction, Medical Imaging, Magnetic Resonance Imaging, Imaging, Three-Dimensional

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.

Interventions

DIAGNOSTIC_TESTMRI

MRI examination with Black Bone, and ultrashort/zero echo time MRI techniques

Sponsors

Great Ormond Street Hospital for Children NHS Foundation Trust
CollaboratorOTHER
Oxford University Hospitals NHS Trust
CollaboratorOTHER
Cambridge University Hospitals NHS Foundation Trust
CollaboratorOTHER
University of Cambridge
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Months to 2 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of craniosynostosisAverage 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 MRIPreliminary 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

Countries

United Kingdom

Contacts

Primary ContactClinical Lecturer
kae34@cam.ac.uk01223 336890

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026