Brain Neoplasms, Brain Neoplasms, Childhood, Brain Tumor, Diagnosis, Image, Magnetic Resonance Imaging, Neuroimaging, Pediatric
Conditions
Keywords
Neuro, Imaging, MRI, Diagnostic accuracy, Neuroimaging, Fast MRI, Neuromix, Pediatric
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTFast MRI (Neuromix)
Diagnostic performance, correlation, agreement
Sponsors
Karolinska University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance | Through study completion, an average of 1 year | AUC, area under the curve for the comparison of the new method against the reference standard |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Imaging artifacts | through study completion, an average of 1 year | Image artifacts on both methods |
| Imaging quality | through study completion, an average of 1 year | Image quality on both methods |
| Correlation | through study completion, an average of 1 year | Correlation between readers and methods |
| Agreement | through study completion, an average of 1 year | Agreement between readers and methods |
| Sensitivity | through study completion, an average of 1 year | Sensitivity of the new method against the reference standard |
| Specificity | through study completion, an average of 1 year | Specificity of the new method against the reference standard |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORAnna Falk Delgado, Ass Prof
Karolinska Institutet
Outcome results
None listed