Fast Brain MRI in Children With Suspected Brain Tumor

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 1 Month - 18 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05776602
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Karolinska University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Anna Falk Delgado, Ass Prof
Principal Investigator Affiliation Karolinska Institutet
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Magnetic Resonance Imaging, Brain Neoplasms, Childhood, Brain Neoplasms, Brain Tumor, Diagnosis, Image, Neuroimaging, Pediatric
Additional Details

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.

Arms & Interventions

Arms

: Pediatric patients with suspected or confirmed brain tumor

New method och standard MRI in clinical care

Interventions

Diagnostic Test: - Fast MRI (Neuromix)

Diagnostic performance, correlation, agreement

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Karolinksa Universitetssjukhuset, Stockholm, Sweden

Status

Recruiting

Address

Karolinksa Universitetssjukhuset

Stockholm, , Eugeniavägen 3

Site Contact

Anna Falk Delgado

[email protected]

0046812370000

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