NCT04695938

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

Status unknown NA Last updated 5 January 2021

What this trial tests

NA trial testing MRI in Craniosynostoses in 80 participants. Status unknown.

Timeline

27 November 2020

Primary endpoint
31 July 2023

31 July 2023

Quick facts

Lead sponsor	University of Cambridge
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	80
Start date	27 November 2020
Primary completion	31 July 2023
Estimated completion	31 July 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• MRI — full drug profile →

Conditions studied

• Craniosynostoses — all drugs for Craniosynostoses →
• Synostosis — all drugs for Synostosis →
• Skull Deformity — all drugs for Skull Deformity →

Sponsor

University of Cambridge

Who can join

Adults 0 Months to 2, any sex, with Craniosynostoses or Synostosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Imaging in Craniofacial Disorders With Special Emphasis on Gradient Echo Black-Bone and Zero Time Echo MRI Sequences.
   Ganau M, Syrmos NC, Magdum SA. · · 2022 · cited 4× · PMID 36388002 · DOI 10.4103/jpn.jpn_46_22