Fast Brain MRI in Children With Suspected Brain Tumor

Brain Tumor Clinical Trial

— Fast MRI  

Official title:

Fast Brain MRI in Children With Suspected or Confirmed Brain Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776602
• Other study ID #: Fast Brain MRI in children
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Karolinska University Hospital
• Contact: Anna Falk Delgado
• Phone: 0046812370000
• Email: anna.falk.delgado[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Fast MRI (Neuromix)
Diagnostic performance, correlation, agreement

Locations

Country	Name	City	State
Sweden	Karolinksa Universitetssjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance	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	Imaging artifacts	Image artifacts on both methods	through study completion, an average of 1 year
Secondary	Imaging quality	Image quality on both methods	through study completion, an average of 1 year
Secondary	Correlation	Correlation between readers and methods	through study completion, an average of 1 year
Secondary	Agreement	Agreement between readers and methods	through study completion, an average of 1 year
Secondary	Sensitivity	Sensitivity of the new method against the reference standard	through study completion, an average of 1 year
Secondary	Specificity	Specificity of the new method against the reference standard	through study completion, an average of 1 year