Comparing MRI to CT on Pediatric Craniosynostosis.

Not Applicable

• Conditions: Craniosynostosis
• Interventions: Diagnostic Test: Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)

• Registration Number: NCT04704284
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-14
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-11
• Status Verified: 2024-05
• Primary Completion: 2024-05-17
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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.

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Exclusion Criteria

• Lack of consent
• Contraindication/inability to undergo both examinations within the designated time period and/or undiagnostic image quality.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZTE MRI Imaging	Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)	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)

Primary Outcome Measures

Name	Time	Method
Concordance between ZTE and CT imaging diagnosis	2 years	90% or greater concordance between ZTE and CT findings, established by evaluating at least 37 patients over the course of two years

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States