Fast Brain MRI in Children With Suspected Brain Tumor

Trial Title: Fast Brain MRI in Children With Suspected Brain Tumor

NCT ID: NCT05776602

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

Conditions: Official terms:
Neoplasms
Brain Neoplasms

Conditions: Keywords:
Neuro
Imaging
MRI
Diagnostic accuracy
Neuroimaging
Fast MRI
Neuromix
Pediatric

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Fast MRI (Neuromix)
Description: Diagnostic performance, correlation, agreement
Arm group label: Pediatric patients with suspected or confirmed brain tumor

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

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 1 Month

Maximum age: 18 Years

Healthy volunteers: No

Locations:

Facility:
Name: Karolinksa Universitetssjukhuset

Address:
City: Stockholm
Zip: Eugeniavägen 3
Country: Sweden

Status: Recruiting

Contact:
Last name: Anna Falk Delgado
Email: anna.falk-delgado@neuroradkarolinska.se

Start date: May 1, 2023

Completion date: December 2025

Lead sponsor:
Agency: Karolinska University Hospital
Agency class: Other

Source: Karolinska University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05776602