Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT05776602
Status:
RECRUITING
Last Update Posted:
2023-10-17
First Post:
2023-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fast Brain MRI in Children With Suspected Brain Tumor
Sponsor:
Karolinska University Hospital
Organization:
Study Overview
Official Title:
Fast Brain MRI in Children With Suspected or Confirmed Brain Tumor
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Fast MRI
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: