EPIMix Versus CT Brain Pediatric Study

NCT ID: NCT03847051

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-15

Study Completion Date

2022-07-30

Brief Summary

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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

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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.

Conditions

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Brain Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MRI

Brain MRI without intravenous contrast

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anna Falk Delgado

Principal Investigator, Medical doctor, PhD, Specialist in Neuroradiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 38267889 (View on PubMed)

Other Identifiers

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EPIMix pediatric

Identifier Type: -

Identifier Source: org_study_id

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