Comparing MRI to CT on Pediatric Craniosynostosis. | NCT04704284

NCT04704284

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Julie B Guerin, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Arm/Group Information

ID	Title	Description
FG000	ZTE MRI Imaging	Pediatric patients that had a clinically indicated CT within a 6 week time period received a Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	ZTE MRI Imaging	Pediatric patients that had a clinically indicated CT within a 6 week time period received a Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) 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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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).

2 participants data was unanalyzable due to motion artifact.

Posted

Count of Participants

Participants

1 Day

ID	Title	Description
OG000	ZTE MRI Imaging	Pediatric patients that had a clinically indicated CT within a 6 week time period received a Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ZTE MRI Imaging	Pediatric patients that had a clinically indicated CT within a 6 week time period received a Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) 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.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Julie Guerin, M.D.	Mayo Clinic	507-293-3698		Guerin.Julie@mayo.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 23, 2022	May 9, 2025	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D013580	Synostosis
D004413	Dysostoses
D001848	Bone Diseases, Developmental
D001847	Bone Diseases