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

Craniosynostoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04695938
• Other study ID #: 18/WA/0155
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: January 2021
• Source: University of Cambridge
• Contact: Clinical Lecturer
• Phone: 01223 336890
• Email: kae34[@]cam.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Craniosynostoses
• Skull Deformity
• Synostosis

Intervention

Diagnostic Test:
• MRI
MRI examination with Black Bone, and ultrashort/zero echo time MRI techniques

Locations

Country	Name	City	State
United Kingdom	University of Cambridge	Cambridge

Sponsors (4)

Lead Sponsor	Collaborator
University of Cambridge	Cambridge University Hospitals NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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)