Craniosynostosis
Conditions
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.
Interventions
DIAGNOSTIC_TESTZero 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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 90% or Greater Concordance Between ZTE and CT Imaging Diagnosis | 1 Day | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | ZTE MRI Imaging |
|---|---|
| Age, Continuous | 7.6 Months STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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).
Time frame: 1 Day
Population: 2 participants data was unanalyzable due to motion artifact.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ZTE MRI Imaging | Number of Participants With 90% or Greater Concordance Between ZTE and CT Imaging Diagnosis | 9 Participants |