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

May 29, 2026 updated by: Anna Falk Delgado, Karolinska University Hospital

Fast Brain MRI in Children With Suspected or Confirmed 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, Eugeniavägen 3
        • Karolinksa Universitetssjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children up to 18 years with suspected or confirmed brain tumor investigated in standard clinical care with MRI of the brain.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging artifacts
Time Frame: through study completion, an average of 1 year
Image artifacts on both methods
through study completion, an average of 1 year
Imaging quality
Time Frame: through study completion, an average of 1 year
Image quality on both methods
through study completion, an average of 1 year
Correlation
Time Frame: through study completion, an average of 1 year
Correlation between readers and methods
through study completion, an average of 1 year
Agreement
Time Frame: through study completion, an average of 1 year
Agreement between readers and methods
through study completion, an average of 1 year
Sensitivity
Time Frame: through study completion, an average of 1 year
Sensitivity of the new method against the reference standard
through study completion, an average of 1 year
Specificity
Time Frame: through study completion, an average of 1 year
Specificity of the new method against the reference standard
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Anna Falk Delgado, Ass Prof, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fast Brain MRI in children

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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