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

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.

Study Overview

• Status: Recruiting
• Conditions: Craniosynostoses; Synostosis; Skull Deformity
• Intervention / Treatment: Diagnostic test: MRI

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Lecturer; Phone Number: 01223 336890; Email: kae34@cam.ac.uk

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • University of Cambridge
    • Contact: Karen Eley; Phone Number: 01223 336890; Email: kae34@cam.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: MRI; MRI examination	Diagnostic test: MRI; MRI examination with Black Bone, and ultrashort/zero echo time MRI techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Cambridge
• Collaborators: Cambridge University Hospitals NHS Foundation Trust; Oxford University Hospitals NHS Trust; Great Ormond Street Hospital for Children NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 27, 2020
• Primary Completion (ANTICIPATED): July 31, 2023
• Study Completion (ANTICIPATED): July 31, 2023

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: January 3, 2021
• First Posted (ACTUAL): January 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 3, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Imaging, Three-Dimensional; Image Reconstruction; Medical Imaging
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Dysostoses; Craniosynostoses; Synostosis
• Other Study ID Numbers: 18/WA/0155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No