Fast MRI Compared to Routine Clinical MRI in Children With Brain Tumor

Sponsor

Karolinska University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05776602

Collaborator

(none)

Enrollment

33.1

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Magnetic Resonance Imaging Brain Neoplasms, Childhood Brain Neoplasms Brain Tumor Diagnosis Image Neuroimaging Pediatric	Diagnostic Test: Fast MRI (Neuromix)

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 in a pediatric population. The primary outcome is the depiction and characterization of brain tumor pathology. Sensitivity, specificity, AUC and intra-/ interreader agreement for the diagnostic performance of Neuromix compared to cMRI will be obtained.

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Fast MRI Compared to Routine Clinical MRI in Children With Brain Tumor

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Pediatric patients with suspected or confirmed brain tumor New method och standard MRI in clinical care	Diagnostic Test: Fast MRI (Neuromix) Diagnostic performance, correlation, agreement

Arm

Intervention/Treatment

Pediatric patients with suspected or confirmed brain tumor

New method och standard MRI in clinical care

Diagnostic Test: Fast MRI (Neuromix)

Diagnostic performance, correlation, agreement

Outcome Measures

Primary Outcome Measures

Diagnostic performance [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 Outcome Measures

Imaging artifacts [through study completion, an average of 1 year]
Image artifacts on both methods
Imaging quality [through study completion, an average of 1 year]
Image quality on both methods
Correlation [through study completion, an average of 1 year]
Correlation between readers and methods
Agreement [through study completion, an average of 1 year]
Agreement between readers and methods
Sensitivity [through study completion, an average of 1 year]
Sensitivity of the new method against the reference standard
Specificity [through study completion, an average of 1 year]
Specificity of the new method against the reference standard