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Status unknownNCT04695938Updated Jan 5, 2021

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

An interventional study of MRI in Craniosynostoses, Synostosis and Skull Deformity, sponsored by University of Cambridge. Status unknown at 1 site in United Kingdom. Open to participants aged 0 Months to 2 Years. Per ClinicalTrials.gov, last updated 2021-01-05.

Sponsored by University of Cambridge · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
0 Months to 2 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Craniosynostoses
  • Synostosis
  • Skull Deformity

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Keywords

  • Image Reconstruction
  • Medical Imaging
  • Magnetic Resonance Imaging
  • Imaging, Three-Dimensional
03

In context

Craniosynostoses

51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.

This study's planned enrollment of 80 is above the median of 27 across 22 interventional studies indexed under Craniosynostoses.

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Lead sponsor

University of Cambridge is the lead sponsor of 116 studies on the registry; 23 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Months to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children in whom craniosynostosis is clinically suspected

Exclusion criteria

Exclusion Criteria:

  • Children with to MRI examination
  • Children who require sedation/anaesthesia solely for the purpose of research MRI
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Other
    MRI

    MRI examination

    Diagnostic Test: MRI

Interventions

  • Diagnostic testMRI

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

06

What researchers measure

Primary outcomes

  1. Diagnosis of craniosynostosis

    Accuracy of diagnosis on MRI of craniosynostosis

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

  2. 3D reconstruction of craniofacial MRI

    Automated segmentation of craniofacial MRI

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

07

Study locations

1 of 1 sites recruiting
  • University of Cambridge
    Cambridge, CB2 0QQ, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2020 (actual). Primary completion is estimated for Jul 2023, 32 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2020
First posted
Jan 5, 2021
StartActual
Nov 27, 2020
Primary completionEst.
Jul 31, 2023
CompletionEst.
Jul 31, 2023
Last update
Jan 5, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04695938
Lead sponsor
University of Cambridge
Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust, Oxford University Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust
Responsible party
Dr Karen A Eley (Clinical Lecturer in Radiology, University of Cambridge) — Principal investigator
First posted
Jan 5, 2021
Start date
Nov 27, 2020
Primary completion
Jul 31, 2023 (estimated)
Completion
Jul 31, 2023 (estimated)
Last update
Jan 5, 2021

Study contacts

Clinical Lecturer
Contact
kae34@cam.ac.uk
01223 336890

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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