Fast Brain MRI in Children With Suspected or Confirmed Brain Tumor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Magnetic Resonance Imaging
- Sponsor
- Karolinska University Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Diagnostic performance
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Anna Falk Delgado
MD, associate professor
Karolinska University Hospital
Eligibility Criteria
Inclusion Criteria
- •Age 0-18 years.
- •Pediatric subjects with diagnosed or suspected brain tumor
- •Referral routine MRI study.
Exclusion Criteria
- •MRI planned without sedation
- •Aborted MR exam
- •Unstable patient
Outcomes
Primary Outcomes
Diagnostic performance
Time Frame: Through study completion, an average of 1 year
AUC, area under the curve for the comparison of the new method against the reference standard
Secondary Outcomes
- Imaging quality(through study completion, an average of 1 year)
- Agreement(through study completion, an average of 1 year)
- Sensitivity(through study completion, an average of 1 year)
- Imaging artifacts(through study completion, an average of 1 year)
- Correlation(through study completion, an average of 1 year)
- Specificity(through study completion, an average of 1 year)