ZTE MRI vs CT for Craniosynostosis

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Lack of consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) for craniosynostosis?

ZTE MRI is effective for imaging cranial bones without using radiation, making it a good alternative to CT scans for diagnosing craniosynostosis. It provides clear images of bone structures and is particularly useful for children, as it avoids the risks associated with radiation exposure. ^{1 2 3 4 5}

Is Zero Echo Time MRI safe for humans?

Zero Echo Time MRI is considered safe as it does not use ionizing radiation, unlike CT scans, making it a safer alternative for imaging, especially in sensitive areas like the head and neck. ^{2 5 6 7 8}

How does ZTE MRI differ from other treatments for craniosynostosis?

ZTE MRI is unique because it provides high-resolution images of bones without using ionizing radiation, unlike CT scans. This makes it a safer option for imaging in sensitive areas like the head, especially in children, and it offers rapid, quiet scans with less risk of artifacts. ^{2 9 10 11 12}

Research Team

Julie B Guerin, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for children and teenagers aged 0-18 who may have craniosynostosis, a condition affecting skull growth. They must be considered for potential skull reconstruction surgery and able to undergo both MRI and CT scans within a specific timeframe.

Inclusion Criteria

I am under 18 and may need skull surgery for craniosynostosis.

Exclusion Criteria

You are unable to complete the required medical exams within the given time frame or the images produced during the exam are not clear enough to provide a diagnosis.

Lack of consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Pediatric patients receive a Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) after having a clinically indicated CT

6 weeks

Follow-up

Participants are monitored for concordance between ZTE and CT imaging diagnosis

2 years

Treatment Details

Interventions

• Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)

Trial Overview The study aims to compare the effectiveness of Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) with traditional CT scans in diagnosing craniosynostosis in pediatric patients.

Participant Groups

Group I: ZTE MRI Imaging Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Craniosynostosis : correlation with cranial vault shape and osseous defects. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Zero-TE MRI: principles and applications in the head and neck. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

MRI Protocol for Craniosynostosis: Replacing Ionizing Radiation-Based CT. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Prenatal diagnosis of craniosynostosis: value of MR imaging. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Multispiral three-dimensional computed tomography in the investigation of craniosynostosis: technique optimization. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

Dedicated sub 0.1 mSv 3DCT using MBIR in children with suspected craniosynostosis: quality assessment. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Pediatric craniosynostosis computed tomography: an institutional experience in reducing radiation dose while maintaining diagnostic image quality. [2022]

8. England pubmed.ncbi.nlm.nih.gov

ViceCT and whiceCT for simultaneous high-resolution visualization of craniofacial, brain and ventricular anatomy from micro-computed tomography. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Automated 3D MRI rendering of the craniofacial skeleton: using ZTE to drive the segmentation of black bone and FIESTA-C images. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Zero-TE MRI: Potential Applications in the Oral Cavity and Oropharynx. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Zero Echo Time Musculoskeletal MRI: Technique, Optimization, Applications, and Pitfalls. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Technical Developments: Zero Echo Time Imaging of the Shoulder: Enhanced Osseous Detail by Using MR Imaging. [2021]