EPIMix Versus CT Brain Pediatric Study

Completed

• Conditions: Brain Diseases

• Registration Number: NCT03847051
• Lead Sponsor: Karolinska University Hospital

Brief Summary

This study aims to assess the diagnostic feasibility and diagnostic performance of a new fast MR sequence EPIMix for neuroradiological evaluation in comparison to computed tomography of brain in pediatric population.

Detailed Description

The study aims to assess the feasibility of fast MR sequence for neuroradiological evaluation in comparison to computed tomography of brain in pediatric population. Imaging quality is analysed with regards to artefacts and lesion conspicuity as well as its diagnostic potential in rendering a probable diagnosis. The primary study aim is to define feasibility and the AUC for diagnostic performance of minute MRI compared to computed tomography.

Included patients are children age 4-18 with suspicion of cerebral pathology with referral to elective computed tomography of the brain.

Study participants are in addition to computed tomography investigated during same day at 3T MR.

Study Timeline

• Study First Submitted: 2019-02-12
• Study Start: 2019-02-15
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Primary Completion: 2020-03-10
• Study Completion: 2022-07-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Age 4-18 years.
• Patient with suspicion of cerebral pathology.
• Referral to elective brain CT study.

Exclusion Criteria

• CT planned with sedation
• known previous cerebral pathology (follow up study)
• Emergency CT
• Aborted MR exam

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic potential	At 0 hours	Diagnostic accuracy to categorize scan as normal or abnormal on a five point Likert scale (1 - definitely normal, 2 - Probably normal, 3 - Indeterminate, 4 - Probably abnormal, 5 - Definitely abnormal) compared to abnormal/normal brain CT.
Tolerance of a new fast MR method in children	At 0 hours	Number of aborted MR

Secondary Outcome Measures

Name	Time	Method
Artefacts	At 0 hours	Artefacts and impact (Motion, Beam hardening, Other) defined as; Not present, Not affecting diagnostic confidence, Degrading diagnostic confidence)
Lesion classification	At 0 hours	Classification into disease categories (Neoplastic, Ischemic, Hemorrhagic, Infection, Neuroinflammation, Hydrocephalus, Congenital malformation, Indeterminate)
Lesion location determination	At 0 hours	Anatomical localization of abnormality (Cerebrum, Cerebellum, Brainstem, Intraventricular, Subarachnoid space including basal cisterns, Intra-orbital, Skull/Skull base/dural, Other)
Lesion description	At 0 hours	For example effect on brain parenchyma and size
Clinical diagnostic summary report	At 0 hours	Text (one sentence summary of the finding including type of lesion and location)
Diagnostic imaging quality	At 0 hours	Diagnostic imaging quality (5 point Likert scale; 1 - Excellent diagnostic imaging quality, 2 - Good diagnostic imaging quality, 3 - Sufficient diagnostic imaging quality, 4 - Restricted diagnostic imaging quality, 5 - Poor diagnostic imaging quality)
Diagnostic confidence	At 0 hours	Five point Likert scale (Very confident, Predominantly confident, Fairly confident, Only slightly confident, Not at all confident)
Ability to rule out diseases	At 0 hours	A list of diseases. Number of positive versus negative cases for each investigation (including: Tumor, Abscess, Parenchymal Haemorrhage, Acute Ischemia, Hydrocephalus, Neuroinflammation, Subarachnoid hemorrhage, Extraaxial fluid collection)

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden