CraniosynostosisNCT04704284
Comparing MRI to CT on Pediatric Craniosynostosis.
A study testing Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) in people with Craniosynostosis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Craniosynostosis
- What is being tested?
- Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2020to 17 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Lack of consent
- Contraindication/inability to undergo both examinations within the designated time period and/or undiagnostic image quality.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Comparative Analysis of Zero Echo-time MRI and CT for Pediatric Craniosynostosis
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.
- Conditions
- Craniosynostosis
- Being tested
- Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)
- Medical subject headings
- Craniosynostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start14 Apr 2020
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CraniosynostosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie B. Guerin, Mayo Clinic
- Investigators
- Julie B Guerin, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704284
- Sponsor's protocol ID
- 19-007373
- Status last verified
- Jun 2025
- First submitted
- 8 Dec 2020
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Zero Echo-time MRI and CT for Pediatric Craniosynostosis
- ClinicalTrials.gov ID
- NCT04704284
- Acronym / sponsor ID
- 19-007373
- Conditions
- Craniosynostosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Posted 17 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZTE MRI Imaging | Experimental | Diagnostic Test: Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)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) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Lack of consent
- Contraindication/inability to undergo both examinations within the designated time period and/or undiagnostic image quality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | ZTE MRI Imaging |
Primary outcome
Number of Participants With 90% or Greater Concordance Between ZTE and CT Imaging Diagnosis
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie B Guerin, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) in people with Craniosynostosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With 90% or Greater Concordance Between ZTE and CT Imaging Diagnosis (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.