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Fast Brain MRI in Children With Suspected or Confirmed Brain Tumor
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.
Age
0 - 18 years
Sex
ALL
Healthy Volunteers
No
Karolinksa Universitetssjukhuset
Stockholm, Sweden
Start Date
May 1, 2023
Primary Completion Date
December 1, 2024
Completion Date
December 1, 2025
Last Updated
October 17, 2023
50
ESTIMATED participants
Fast MRI (Neuromix)
DIAGNOSTIC_TEST
Lead Sponsor
Karolinska University Hospital
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04866940