Brain DiseasesNCT03847051
EPIMix Versus CT Brain Pediatric Study
An observational study of Brain Diseases, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Brain Diseases
- What is being tested?
- MRI
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 15 Feb 2019to 30 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Child with indication for elective brain CT.
Who may be able to join
- Age 4-18 years.
- Patient with suspicion of cerebral pathology.
- Referral to elective brain CT study.
Who cannot join
- CT planned with sedation
- known previous cerebral pathology (follow up study)
- Emergency CT
- Aborted MR exam
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EPIMix (Echo Planar Imaging Mix) 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.
Read the 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.
- Conditions
- Brain Diseases
- Being tested
- MRI
- Keywords
- MRI (magnetic resonance imaging), Neuroradiology, EPIMix (Echo planar imaging mix), Multicontrast EPI (echo planar imaging), Clinical validation
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Brain MRI without intravenous contrast
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of a new fast MR method in children
Number of aborted MR
Measured: 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.
Measured: At 0 hours
Secondary outcomes (8)
Lesion classification
Classification into disease categories (Neoplastic, Ischemic, Hemorrhagic, Infection, Neuroinflammation, Hydrocephalus, Congenital malformation, Indeterminate)
Measured: At 0 hours
Lesion location determination
Anatomical localization of abnormality (Cerebrum, Cerebellum, Brainstem, Intraventricular, Subarachnoid space including basal cisterns, Intra-orbital, Skull/Skull base/dural, Other)
Measured: At 0 hours
Diagnostic imaging quality
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)
Measured: At 0 hours
Lesion description
For example effect on brain parenchyma and size
Measured: At 0 hours
Diagnostic confidence
Five point Likert scale (Very confident, Predominantly confident, Fairly confident, Only slightly confident, Not at all confident)
Measured: At 0 hours
Clinical diagnostic summary report
Text (one sentence summary of the finding including type of lesion and location)
Measured: At 0 hours
Ability to rule out diseases
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)
Measured: At 0 hours
Artefacts
Artefacts and impact (Motion, Beam hardening, Other) defined as; Not present, Not affecting diagnostic confidence, Degrading diagnostic confidence)
Measured: At 0 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start15 Feb 2019
- Primary completion10 Mar 2020
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Anna Falk Delgado, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847051
- Sponsor's protocol ID
- EPIMix pediatric
- Status last verified
- Oct 2023
- First submitted
- 12 Feb 2019
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38267889
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPIMix (Echo Planar Imaging Mix) Versus CT Brain Pediatric Study
- ClinicalTrials.gov ID
- NCT03847051
- Acronym / sponsor ID
- EPIMix pediatric
- Conditions
- Brain Diseases
- Keywords
- MRI (magnetic resonance imaging), Neuroradiology, EPIMix (Echo planar imaging mix), Multicontrast EPI (echo planar imaging), Clinical validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Child with indication for elective brain CT.
Key inclusion criteria (3 listed)
- Age 4-18 years.
- Patient with suspicion of cerebral pathology.
- Referral to elective brain CT study.
Key exclusion criteria (4 listed)
- CT planned with sedation
- known previous cerebral pathology (follow up study)
- Emergency CT
- Aborted MR exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIBrain MRI without intravenous contrast | Diagnostic test | – |
Primary outcome
Tolerance of a new fast MR method in children
Time frame: At 0 hours
Number of aborted MR
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.
8 secondary outcomes
Lesion classification
Time frame: At 0 hours
Lesion location determination
Time frame: At 0 hours
Diagnostic imaging quality
Time frame: At 0 hours
Lesion description
Time frame: At 0 hours
Diagnostic confidence
Time frame: At 0 hours
Clinical diagnostic summary report
Time frame: At 0 hours
Ability to rule out diseases
Time frame: At 0 hours
Artefacts
Time frame: At 0 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Derived from this study: PubMed 38267889De 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Diseases, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of a new fast MR method in children (time frame: At 0 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03847051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.