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Completed

NCT Number: NCT03847051

EPIMix Versus CT Brain Pediatric Study

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.

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Key information

Conditions

Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Diagnostic Test

Brain MRI without intravenous contrast

Primary outcomes

  1. Tolerance of a new fast MR method in children

    Time frame: At 0 hours

    Number of aborted MR

  2. Diagnostic potential

    Time frame: 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.

Secondary outcomes

  1. Lesion classification

    Time frame: At 0 hours

    Classification into disease categories (Neoplastic, Ischemic, Hemorrhagic, Infection, Neuroinflammation, Hydrocephalus, Congenital malformation, Indeterminate)

  2. Lesion location determination

    Time frame: At 0 hours

    Anatomical localization of abnormality (Cerebrum, Cerebellum, Brainstem, Intraventricular, Subarachnoid space including basal cisterns, Intra-orbital, Skull/Skull base/dural, Other)

  3. Diagnostic imaging quality

    Time frame: 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)

  4. Lesion description

    Time frame: At 0 hours

    For example effect on brain parenchyma and size

  5. Diagnostic confidence

    Time frame: At 0 hours

    Five point Likert scale (Very confident, Predominantly confident, Fairly confident, Only slightly confident, Not at all confident)

  6. Clinical diagnostic summary report

    Time frame: At 0 hours

    Text (one sentence summary of the finding including type of lesion and location)

  7. Ability to rule out diseases

    Time frame: 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)

  8. Artefacts

    Time frame: At 0 hours

    Artefacts and impact (Motion, Beam hardening, Other) defined as; Not present, Not affecting diagnostic confidence, Degrading diagnostic confidence)

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • GE Healthcare

Registry information

Official study title

EPIMix (Echo Planar Imaging Mix) Versus CT Brain Pediatric Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Feb 20, 2019
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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