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NCT04704284 Clinical Trial

Comparing MRI to CT on Pediatric Craniosynostosis.

Craniosynostosis Clinical Trial

Official title:
Comparative Analysis of Zero Echo-time MRI and CT for Pediatric Craniosynostosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04704284
Other study ID # 19-007373
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 14, 2020
Est. completion date April 2026

Study information
Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 40
Est. completion date April 2026
Est. primary completion date May 17, 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)
Magnetic Resonance Imaging (MRI) with zero echo-time (ZTE) that uses proton density differences rather than T2 relaxation time differences to achieve contrast.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concordance between ZTE and CT imaging diagnosis 90% or greater concordance between ZTE and CT findings, established by evaluating at least 37 patients over the course of two years 2 years
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