Comparative Analysis of Zero Echo-time MRI and CT for Pediatric Craniosynostosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Number of Participants With 90% or Greater Concordance Between ZTE and CT Imaging Diagnosis
Study Overview
Brief Summary
The purpose of this study is to develop and test the effectiveness and diagnostic quality of Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) in comparison to CT.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pediatric patients 0-18 of age will be recruited by our surgical colleagues based on the clinical concern for craniosynostosis and possible need for calvarial reconstruction.
Exclusion Criteria
- •Lack of consent
- •Contraindication/inability to undergo both examinations within the designated time period and/or undiagnostic image quality.
Arms & Interventions
ZTE MRI Imaging
Pediatric patients that have gotten a clinically indicated CT within a 6 week time period will receive a Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)
Intervention: Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) (Diagnostic Test)
Outcomes
Primary Outcomes
Number of Participants With 90% or Greater Concordance Between ZTE and CT Imaging Diagnosis
Time Frame: 1 Day
In the context of our study, concordance refers to the level of agreement between two radiologists in their interpretation of imaging findings across the two modalities (ZTE and CT).
Secondary Outcomes
No secondary outcomes reported
Investigators
Julie B. Guerin
Principal Investigator
Mayo Clinic