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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric patients with suspected or confirmed brain tumor | New method och standard MRI in clinical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast MRI (Neuromix) | Diagnostic Test | Diagnostic performance, correlation, agreement |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Children up to 18 years with suspected or confirmed brain tumor investigated in standard clinical care with MRI of the brain.
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| Name | Affiliation | Role |
|---|---|---|
| Anna Falk Delgado, Ass Prof | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinksa Universitetssjukhuset | Stockholm | Stockholm County | Eugeniavägen 3 | Sweden |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |