Fast Brain MRI in Children With Suspected Brain Tumor

Recruiting

• Conditions: Diagnosis; Brain Neoplasms, Childhood; Image; Magnetic Resonance Imaging; Brain Neoplasms; Neuroimaging; Brain Tumor; Pediatric
• Interventions: Diagnostic Test: Fast MRI (Neuromix)

• Registration Number: NCT05776602
• Lead Sponsor: Karolinska University Hospital

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.

Study Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-20
• Study Start: 2023-05-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric patients with suspected or confirmed brain tumor	Fast MRI (Neuromix)	New method och standard MRI in clinical care

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Imaging quality	through study completion, an average of 1 year	Image quality on both 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
Imaging artifacts	through study completion, an average of 1 year	Image artifacts on both methods
Correlation	through study completion, an average of 1 year	Correlation between readers and methods
Specificity	through study completion, an average of 1 year	Specificity of the new method against the reference standard

Trial Locations

Locations (1)

Karolinksa Universitetssjukhuset; 🇸🇪 Stockholm, Sweden