Craniofacial Imaging With 3D MRI: an Alternative to Ionising Radiation
NCT04695938 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2021-01-05
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
Interventions
- DIAGNOSTIC_TEST
-
MRI
MRI examination with Black Bone, and ultrashort/zero echo time MRI techniques
Sponsors & Collaborators
-
Great Ormond Street Hospital for Children NHS Foundation Trust
collaborator OTHER -
Oxford University Hospitals NHS Trust
collaborator OTHER -
Cambridge University Hospitals NHS Foundation Trust
collaborator OTHER - lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 0 Months
- Max Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-27
- Primary Completion
- 2023-07-31
- Completion
- 2023-07-31
Countries
- United Kingdom
Study Locations
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