Comparing MRI to CT on Pediatric Craniosynostosis.

NCT04704284 | Completed Results FDA Device

• 1 other identifier: 19-007373
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniosynostosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 90% or Greater Concordance Between ZTE and CT Imaging Diagnosis

  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).

  1 Day

Study Arms (1)

ZTE MRI Imaging

EXPERIMENTAL

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)

Diagnostic Test: Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)

Interventions

Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) DIAGNOSTIC_TEST

Magnetic Resonance Imaging (MRI) with zero echo-time (ZTE) that uses proton density differences rather than T2 relaxation time differences to achieve contrast.

ZTE MRI Imaging

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Craniosynostoses

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Julie Guerin, M.D.
• Organization: Mayo Clinic

Guerin.Julie@mayo.edu

507-293-3698

Study Officials

• Julie B Guerin, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: January 11, 2021
• Study Start: April 14, 2020
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-06

Locations

US (1)