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Completed

NCT Number: NCT05776602

Fast Brain MRI in Children With Suspected Brain Tumor

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

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Key information

Conditions

Magnetic Resonance Imaging Brain Diseases Brain Neoplasms Brain Neoplasms, Childhood Brain Tumor Central Nervous System Diseases Central Nervous System Neoplasms Diagnosis Disease Image Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neuroimaging Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinksa Universitetssjukhuset

Stockholm, Stockholm County, Eugeniavägen 3, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fast MRI (Neuromix)

Diagnostic Test

Diagnostic performance, correlation, agreement

Primary outcomes

  1. 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

  1. Imaging artifacts

    Time frame: through study completion, an average of 1 year

    Image artifacts on both methods

  2. Imaging quality

    Time frame: through study completion, an average of 1 year

    Image quality on both methods

  3. Correlation

    Time frame: through study completion, an average of 1 year

    Correlation between readers and methods

  4. Agreement

    Time frame: through study completion, an average of 1 year

    Agreement between readers and methods

  5. Sensitivity

    Time frame: through study completion, an average of 1 year

    Sensitivity of the new method against the reference standard

  6. Specificity

    Time frame: through study completion, an average of 1 year

    Specificity of the new method against the reference standard

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

Fast Brain MRI in Children With Suspected or Confirmed Brain Tumor

Acronym: Fast MRI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2023
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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