Fast Brain MRI in Children With Suspected Brain Tumor (Fast MRI)

Karolinska University Hospital

Status: Enrolling

Conditions: Brain Tumor; Neuroimaging; Diagnosis; Image; Pediatric; Brain Neoplasms, Childhood; Brain Neoplasms; Magnetic Resonance Imaging

Treatments: Diagnostic Test: Fast MRI (Neuromix)

Study type: Observational

Funder types: Other

Identifiers

NCT05776602

Fast Brain MRI in children

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Pediatric patients with suspected or confirmed brain tumor

Description:

New method och standard MRI in clinical care

Treatment:

Diagnostic Test: Fast MRI (Neuromix)