Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2023-05-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pediatric patients with suspected or confirmed brain tumor
New method och standard MRI in clinical care
Fast MRI (Neuromix)
Diagnostic performance, correlation, agreement
Interventions
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Fast MRI (Neuromix)
Diagnostic performance, correlation, agreement
Eligibility Criteria
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Inclusion Criteria
* Pediatric subjects with diagnosed or suspected brain tumor
* Referral routine MRI study.
Exclusion Criteria
* Aborted MR exam
* Unstable patient
1 Month
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Responsible Party
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Anna Falk Delgado
MD, associate professor
Principal Investigators
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Anna Falk Delgado, Ass Prof
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karolinksa Universitetssjukhuset
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Fast Brain MRI in children
Identifier Type: -
Identifier Source: org_study_id
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