Back to resultsComparing MRI to CT on Pediatric Craniosynostosis.
Primary Purpose
Craniosynostosis
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)
Sponsored by
About this trial
This is an interventional other trial for Craniosynostosis
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ZTE MRI Imaging
Arm Description
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04704284
Brief Title
Comparing MRI to CT on Pediatric Craniosynostosis.
Official Title
Comparative Analysis of Zero Echo-time MRI and CT for Pediatric Craniosynostosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniosynostosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ZTE MRI Imaging
Arm Type
Experimental
Arm Description
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 Type
Diagnostic Test
Intervention Name(s)
Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)
Intervention Description
Magnetic Resonance Imaging (MRI) with zero echo-time (ZTE) that uses proton density differences rather than T2 relaxation time differences to achieve contrast.
Primary Outcome Measure Information:
Title
Concordance between ZTE and CT imaging diagnosis
Description
90% or greater concordance between ZTE and CT findings, established by evaluating at least 37 patients over the course of two years
Time Frame
2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie B Guerin, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Comparing MRI to CT on Pediatric Craniosynostosis.
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