NCT05776602

Fast Brain MRI in Children With Suspected Brain Tumor

Fast Brain MRI in Children With Suspected or Confirmed Brain Tumor

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fast MRI (Neuromix)	Diagnostic performance, correlation, agreement

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2023-03-20
• Last updated: 2023-10-17

Locations

1 site across 1 country: Sweden