Magnetic Resonance Imaging in patients with craniosynostosis.

Withdrawn

• Conditions: ontwikkeling van hersenen (in relatie tot het te vroeg sluiten van schedelnaden); Craniosynostosis; premature fusion of the skullsutures; 10027664

• Registration Number: NL-OMON38890
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Patients with one of the following diagnoses:
- Complex craniosynostosis
- Syndromic craniosynostosis
- Trigonocephaly
- Scaphocephaly
And:
- Between 0 and 2 years of age

Exclusion Criteria

Patients with any metallic object in their skull.
Patients with a known allergy to the used anaesthetic agent.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters follow from the MR scan outcomes. The cerebral blood<br /><br>flow will be measured in ml/g/min per region of the brain. DTI data is<br /><br>expressed in fractional anisotropy (FA) and Apparent Diffusion Coefficient<br /><br>(ADC) values for all regions of interest.<br /><br>The endpoint for the individual patient is reached after the last MR scan is<br /><br>made. Standard clinical follow-up will last until the patient is 18 years of<br /><br>age.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>primary study parameters will be correlated to the outcome of neuro-cognitive<br /><br>test performed during standard clinical follow-up.</p><br>