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

NCT04695938 | Unknown

• 1 other identifier: 18/WA/0155
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniosynostoses; Synostosis; Skull Deformity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Diagnosis of craniosynostosis

  Accuracy of diagnosis on MRI of craniosynostosis

  Average one week for diagnosis of individual participants. End of study (2 years) for cohort analysis.

• 3D reconstruction of craniofacial MRI

  Automated segmentation of craniofacial MRI

  Preliminary 3D outputs within 2 weeks of participation per patient, and by end of study for automated segmentation algorithms(2 years)

Study Arms (1)

MRI

OTHER

MRI examination

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

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

MRI

Eligibility Criteria

• Age: 0 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children in whom craniosynostosis is clinically suspected

You may not qualify if:

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

Sponsors & Collaborators

• University of Cambridge: lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

University of Cambridge

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Craniosynostoses; Synostosis

Condition Hierarchy (Ancestors)

Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Clinical Lecturer

CONTACT

01223 336890; kae34@cam.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer in Radiology

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: January 5, 2021
• Study Start: November 27, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

GB (1)