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

Primary Purpose

Craniosynostoses, Synostosis, Skull Deformity

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MRI
Sponsored by
University of Cambridge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Craniosynostoses focused on measuring Image Reconstruction, Medical Imaging, Magnetic Resonance Imaging, Imaging, Three-Dimensional

Eligibility Criteria

0 Months - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of CambridgeRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MRI

Arm Description

MRI examination

Outcomes

Primary Outcome Measures

Diagnosis of craniosynostosis
Accuracy of diagnosis on MRI of craniosynostosis
3D reconstruction of craniofacial MRI
Automated segmentation of craniofacial MRI

Secondary Outcome Measures

Full Information

First Posted
February 7, 2020
Last Updated
January 3, 2021
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
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1. Study Identification

Unique Protocol Identification Number
NCT04695938
Brief Title
Craniofacial Imaging With 3D MRI: an Alternative to Ionising Radiation
Official Title
Craniofacial Imaging With 3D MRI: an Alternative to Ionising Radiation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 27, 2020 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniosynostoses, Synostosis, Skull Deformity
Keywords
Image Reconstruction, Medical Imaging, Magnetic Resonance Imaging, Imaging, Three-Dimensional

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI
Arm Type
Other
Arm Description
MRI examination
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
MRI examination with Black Bone, and ultrashort/zero echo time MRI techniques
Primary Outcome Measure Information:
Title
Diagnosis of craniosynostosis
Description
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.
Title
3D reconstruction of craniofacial MRI
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Lecturer
Phone
01223 336890
Email
kae34@cam.ac.uk
Facility Information:
Facility Name
University of Cambridge
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Eley
Phone
01223 336890
Email
kae34@cam.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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