An interventional study of Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) in Craniosynostosis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Other
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.
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's enrollment of 12 is below the median of 27 across 22 interventional studies indexed under Craniosynostoses.
Browse Craniosynostoses studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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
| Milestone | ZTE MRI Imaging |
|---|---|
| Started | 12 |
| Completed | 11 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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).
| Participants | ZTE MRI Imaging |
|---|---|
| Number of Participants With 90% or Greater Concordance Between ZTE and CT Imaging Diagnosis | 9 |
Collected over Adverse Events were collected from the time the participant signed the informed consent form through the end of study completion, approximately 1 day.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ZTE MRI Imaging | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(Months) | ZTE MRI Imaging |
|---|---|
| Mean | 7.6 ± 4 |
| Sex: Female, Male(Participants) | ZTE MRI Imaging |
|---|---|
| Female | 1 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | ZTE MRI Imaging |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 11 |
| Race (NIH/OMB)(Participants) | ZTE MRI Imaging |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 11 |
| Region of Enrollment(participants) | ZTE MRI Imaging |
|---|---|
| United States | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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