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
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.
Study Type
OBSERVATIONAL
Enrollment
50
Diagnostic performance, correlation, agreement
Karolinksa Universitetssjukhuset
Stockholm, Sweden
RECRUITINGDiagnostic performance
AUC, area under the curve for the comparison of the new method against the reference standard
Time frame: Through study completion, an average of 1 year
Imaging artifacts
Image artifacts on both methods
Time frame: through study completion, an average of 1 year
Imaging quality
Image quality on both methods
Time frame: through study completion, an average of 1 year
Correlation
Correlation between readers and methods
Time frame: through study completion, an average of 1 year
Agreement
Agreement between readers and methods
Time frame: through study completion, an average of 1 year
Sensitivity
Sensitivity of the new method against the reference standard
Time frame: through study completion, an average of 1 year
Specificity
Specificity of the new method against the reference standard
Time frame: through study completion, an average of 1 year
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