EPIMix Versus CT Brain Pediatric Study
EPIMix (Echo Planar Imaging Mix) Versus CT Brain Pediatric Study
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2019
CompletedStudy Start
First participant enrolled
February 15, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2022
CompletedOctober 17, 2023
October 1, 2023
1.1 years
February 12, 2019
October 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Tolerance of a new fast MR method in children
Number of aborted MR
At 0 hours
Diagnostic potential
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.
At 0 hours
Secondary Outcomes (8)
Lesion classification
At 0 hours
Lesion location determination
At 0 hours
Diagnostic imaging quality
At 0 hours
Lesion description
At 0 hours
Diagnostic confidence
At 0 hours
- +3 more secondary outcomes
Interventions
Brain MRI without intravenous contrast
Eligibility Criteria
Child with indication for elective brain CT.
You may qualify if:
- Age 4-18 years.
- Patient with suspicion of cerebral pathology.
- Referral to elective brain CT study.
You may not qualify if:
- CT planned with sedation
- known previous cerebral pathology (follow up study)
- Emergency CT
- Aborted MR exam
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska University Hospitallead
- GE Healthcarecollaborator
Study Sites (1)
Karolinska University Hospital
Stockholm, Sweden
Related Publications (1)
De Luca F, Kits A, Martin Munoz D, Aspelin A, Kvist O, Osterman Y, Diaz Ruiz S, Skare S, Falk Delgado A. Elective one-minute full brain multi-contrast MRI versus brain CT in pediatric patients: a prospective feasibility study. BMC Med Imaging. 2024 Jan 24;24(1):23. doi: 10.1186/s12880-024-01196-6.
PMID: 38267889DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Medical doctor, PhD, Specialist in Neuroradiology
Study Record Dates
First Submitted
February 12, 2019
First Posted
February 20, 2019
Study Start
February 15, 2019
Primary Completion
March 10, 2020
Study Completion
July 30, 2022
Last Updated
October 17, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share