Viewing Study NCT03847051


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Study NCT ID: NCT03847051
Status: COMPLETED
Last Update Posted: 2023-10-17
First Post: 2019-02-12
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: EPIMix Versus CT Brain Pediatric Study
Sponsor: Karolinska University Hospital
Organization:

Study Overview

Official Title: EPIMix (Echo Planar Imaging Mix) Versus CT Brain Pediatric Study
Status: COMPLETED
Status Verified Date: 2023-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: