Fast Brain MRI in Children With Suspected Brain Tumor

Study Overview
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Brief Summary
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This study aims to assess the diagnostic performance of a new fast MRI sequence named Neuromix compared to routine clinical MRI for brain tumor in pediatric patients

Detailed Description
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The study aims to assess the diagnostic performance of fast MR sequence for the radiological evaluation of brain tumor in comparison to routine clinical MRI (or reference standard) in a pediatric population. The primary outcome is the depiction and characterization of normal brain, brain tumor pathology and incidental findings. Sensitivity, specificity, AUC and intra-/ interreader agreement for the diagnostic performance of Neuromix compared to cMRI will be obtained. Correlation of results between methods will be calculated. Secondary outcomes will also include the assessment of diagnostic image quality and image artifacts. The study population will consist of subjects aged 0-18 with a suspected or diagnosed brain tumor referred for routine MRI examination of the brain. Study subjects will be investigated during the same day at 3T MR with Neuromix sequence in addition to the routine MRI examination. Volume measurements will be compared.

Official Title
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Fast Brain MRI in Children With Suspected or Confirmed Brain Tumor

Conditions
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Magnetic Resonance Imaging, Brain Neoplasms, Childhood, Brain Neoplasms, Brain Tumor, Diagnosis, Image, Neuroimaging, Pediatric

Intervention / Treatment
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* Diagnostic Test: Fast MRI (Neuromix)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 0-18 years. Pediatric subjects with diagnosed or suspected brain tumor Referral routine MRI study. Exclusion Criteria: MRI planned without sedation Aborted MR exam Unstable patient

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric patients with suspected or confirmed brain tumor<br>New method och standard MRI in clinical care | Diagnostic Test: Fast MRI (Neuromix)<br>* Diagnostic performance, correlation, agreement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance | AUC, area under the curve for the comparison of the new method against the reference standard | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging artifacts | Image artifacts on both methods | through study completion, an average of 1 year | 
| Imaging quality | Image quality on both methods | through study completion, an average of 1 year | 
| Correlation | Correlation between readers and methods | through study completion, an average of 1 year | 
| Agreement | Agreement between readers and methods | through study completion, an average of 1 year | 
| Sensitivity | Sensitivity of the new method against the reference standard | through study completion, an average of 1 year | 
| Specificity | Specificity of the new method against the reference standard | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuro, Imaging, MRI, Diagnostic accuracy, Neuroimaging, Fast MRI, Neuromix, Pediatric