Trial Outcomes & Findings for Comparing MRI to CT on Pediatric Craniosynostosis. (NCT NCT04704284)

NCT ID: NCT04704284

Last Updated: 2025-07-17

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 1 Day
• Results posted on: 2025-07-17

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Comparing MRI to CT on Pediatric Craniosynostosis.

Baseline characteristics by cohort

Measure	ZTE MRI Imaging n=11 Participants 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.
Age, Continuous	7.6 Months STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

Population: 2 participants data was unanalyzable due to motion artifact.

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).

Outcome measures

Measure	ZTE MRI Imaging n=9 Participants 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.
Number of Participants With 90% or Greater Concordance Between ZTE and CT Imaging Diagnosis	9 Participants

Adverse Events

ZTE MRI Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie Guerin, M.D.

Mayo Clinic

Phone: 507-293-3698

Email: Guerin.Julie@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place