CraniosynostosesNCT04695938
Craniofacial Imaging With 3D MRI: an Alternative to Ionising Radiation
A study testing MRI in people with Craniosynostoses and Synostosis, run by University of Cambridge at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 0 months to 2 years
- Conditions the study is for
- Craniosynostoses, Synostosis, Skull Deformity
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Nov 2020to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children in whom craniosynostosis is clinically suspected
Who cannot join
- Children with contraindications to MRI examination
- Children who require sedation/anaesthesia solely for the purpose of research MRI
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Cambridge
Cambridge, CB2 0QQ
Karen Eley, 01223 336890, kae34@cam.ac.uk
About this study
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.
Read more
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
- Being tested
- MRI
- Keywords
- Image Reconstruction, Medical Imaging, Magnetic Resonance Imaging, Imaging, Three-Dimensional
- Medical subject headings
- Craniosynostoses, Synostosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
MRI examination with Black Bone, and ultrashort/zero echo time MRI techniques
| Study group | Role | What they receive |
|---|---|---|
| MRI | Other | MRI examination Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of craniosynostosis
Accuracy of diagnosis on MRI of craniosynostosis
Measured: 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
Measured: Preliminary 3D outputs within 2 weeks of participation per patient, and by end of study for automated segmentation algorithms(2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start27 Nov 2020
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniosynostosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust, Oxford University Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Karen A Eley, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695938
- Sponsor's protocol ID
- 18/WA/0155
- Status last verified
- Jan 2021
- First submitted
- 7 Feb 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Craniofacial Imaging With 3D MRI: an Alternative to Ionising Radiation
- ClinicalTrials.gov ID
- NCT04695938
- Acronym / sponsor ID
- 18/WA/0155
- Conditions
- Craniosynostoses, Synostosis, Skull Deformity
- Keywords
- Image Reconstruction, Medical Imaging, Magnetic Resonance Imaging, Imaging, Three-Dimensional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust, Oxford University Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | Other | Diagnostic Test: MRIMRI examination |
Who may qualify
- Ages
- 0 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children in whom craniosynostosis is clinically suspected
Key exclusion criteria (2 listed)
- Children with contraindications to MRI examination
- Children who require sedation/anaesthesia solely for the purpose of research MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI examination with Black Bone, and ultrashort/zero echo time MRI techniques | Diagnostic test | MRI |
Primary outcome
Diagnosis of craniosynostosis
Time frame: Average one week for diagnosis of individual participants. End of study (2 years) for cohort analysis.
Accuracy of diagnosis on MRI of craniosynostosis
3D reconstruction 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)
Automated segmentation of craniofacial MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Craniosynostoses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Craniosynostoses and Synostosis, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Lecturer (01223 336890, kae34@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of craniosynostosis (time frame: Average one week for diagnosis of individual participants. End of study (2 years) for cohort analysis.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.