Magnetic Resonance ImagingFast MRINCT05776602
Fast Brain MRI in Children With Suspected Brain Tumor
An observational study of Magnetic Resonance Imaging and Brain Neoplasms, Childhood, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Magnetic Resonance Imaging, Brain Neoplasms, Childhood, Brain Neoplasms
- What is being tested?
- Fast MRI (Neuromix)
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2023to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children up to 18 years with suspected or confirmed brain tumor investigated in standard clinical care with MRI of the brain.
Who may be able to join
- Age 0-18 years.
- Pediatric subjects with diagnosed or suspected brain tumor
- Referral routine MRI study.
Who cannot join
- MRI planned without sedation
- Aborted MR exam
- Unstable patient
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinksa Universitetssjukhuset
Stockholm, Stockholm County, Eugeniavägen 3
About this study
Official title: 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
Read the 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.
- Conditions
- Magnetic Resonance Imaging, Brain Neoplasms, Childhood, Brain Neoplasms, Brain Tumor, Diagnosis, Image
- Being tested
- Fast MRI (Neuromix)
- Keywords
- Neuro, Imaging, MRI, Diagnostic accuracy, Neuroimaging, Fast MRI, Neuromix, Pediatric
- Medical subject headings
- Brain Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast MRI (Neuromix)Diagnostic test
Diagnostic performance, correlation, agreement
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients with suspected or confirmed brain tumor | New method och standard MRI in clinical care Receives: Diagnostic Test: Fast MRI (Neuromix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance
AUC, area under the curve for the comparison of the new method against the reference standard
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Imaging artifacts
Image artifacts on both methods
Measured: through study completion, an average of 1 year
Imaging quality
Image quality on both methods
Measured: through study completion, an average of 1 year
Correlation
Correlation between readers and methods
Measured: through study completion, an average of 1 year
Agreement
Agreement between readers and methods
Measured: through study completion, an average of 1 year
Sensitivity
Sensitivity of the new method against the reference standard
Measured: through study completion, an average of 1 year
Specificity
Specificity of the new method against the reference standard
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 May 2023
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Falk Delgado, Karolinska University Hospital
- Investigators
- Anna Falk Delgado, Ass Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776602
- Sponsor's protocol ID
- Fast Brain MRI in children
- Acronym
- Fast MRI
- Status last verified
- May 2026
- First submitted
- 22 Feb 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Brain MRI in Children With Suspected or Confirmed Brain Tumor
- ClinicalTrials.gov ID
- NCT05776602
- Acronym / sponsor ID
- Fast MRI / Fast Brain MRI in children
- Conditions
- Magnetic Resonance Imaging, Brain Neoplasms, Childhood, Brain Neoplasms, Brain Tumor, Diagnosis, Image
- Keywords
- Neuro, Imaging, MRI, Diagnostic accuracy, Neuroimaging, Fast MRI, Neuromix, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with suspected or confirmed brain tumor | – | Diagnostic Test: Fast MRI (Neuromix)New method och standard MRI in clinical care |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children up to 18 years with suspected or confirmed brain tumor investigated in standard clinical care with MRI of the brain.
Key inclusion criteria (3 listed)
- Age 0-18 years.
- Pediatric subjects with diagnosed or suspected brain tumor
- Referral routine MRI study.
Key exclusion criteria (3 listed)
- MRI planned without sedation
- Aborted MR exam
- Unstable patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast MRI (Neuromix)Diagnostic performance, correlation, agreement | Diagnostic test | Pediatric patients with suspected or confirmed brain tumor |
Primary outcome
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
6 secondary outcomes
Imaging artifacts
Time frame: through study completion, an average of 1 year
Imaging quality
Time frame: through study completion, an average of 1 year
Correlation
Time frame: through study completion, an average of 1 year
Agreement
Time frame: through study completion, an average of 1 year
Sensitivity
Time frame: through study completion, an average of 1 year
Specificity
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Falk Delgado, Ass Prof principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Resonance Imaging and Brain Neoplasms, Childhood, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.