Brain DiseasesNCT03338270
Clinical Validation Study of Multi-EPI Mix
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 validity of a new minute-MRI sequence for neuroradiological evaluation in comparison to conventional MRI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Diseases
- What is being tested?
- MRI
- Type of treatment
- Injection or infusion
- How many people
- 101 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2017to 7 May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Neuroradiological indication for brain MRI
Who may be able to join
- Neuroradiological MRI
Who cannot join
- Aborted exam
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation Study of a Novel Minute MRI Sequence
This study aims to assess the diagnostic validity of a new minute-MRI sequence for neuroradiological evaluation in comparison to conventional MRI.
Read the detailed description
The study aims to assess the imaging quality 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 the AUC for diagnostic performance of minute MRI compared to conventional MRI.
Included patients are those with suspiscion of cerebral pathology.
Study participancts are investigated at 3T.
- Conditions
- Brain Diseases
- Being tested
- MRI
- Keywords
- MRI, Neuroradiology, minute-MRI, multi EPI-mix, 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
MRI sequence without intravenous contrast
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic potential
Diagnostic performance of lesion conspicuity of new MR sequence compared to conventional sequences
Measured: At MRI scan. Diagnostic accuracy to categorize scan as normal or abnormal on a five point Likert scale compared to abnormal/normal conventional MRI.
Secondary outcomes (11)
Lesion location determination
Anatomical localization of abnormality
Measured: At MRI scan
Lesion classification
Classification into disease categories
Measured: At MRI scan
Imaging quality
Artefacts
Measured: At MRI scan
Diagnostic imaging quality
Diagnostic imaging quality
Measured: At MRI scan
Anatomical conspicuity
Specified anatomical structures
Measured: At MRI scan
Multifocality
Determine multifocal lesion
Measured: At MRI scan
Ability to rule out diseases
A list of diseases
Measured: At MRI scan
Lesion description
For example effect on brain parenchyma and size
Measured: At MRI scan
Diagnostic confidence
Scale
Measured: At MRI scan
Brain coverage
Full or lower
Measured: At MRI scan
Clinical diagnostic summay report
Text
Measured: At MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 Dec 2017
- Primary completion7 May 2018
- Study completion7 May 2018
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.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 101 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
- Investigators
- Anna Falk Delgado, MD, PhD, Principal investigator, Clinical Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338270
- Sponsor's protocol ID
- Neuroradiology Karolinska Uni.
- Status last verified
- Oct 2018
- First submitted
- 7 Nov 2017
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Delgado AF, Kits A, Bystam J, Kaijser M, Skorpil M, Sprenger T, Skare S. Diagnostic performance of a new multicontrast one-minute full brain exam (EPIMix) in neuroradiology: A prospective study. J Magn Reson Imaging. 2019 Dec;50(6):1824-1833. doi: 10.1002/jmri.26742. Epub 2019 Apr 1.
PubMed 30932287
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Study of a Novel Minute MRI Sequence
- ClinicalTrials.gov ID
- NCT03338270
- Acronym / sponsor ID
- Neuroradiology Karolinska Uni.
- Conditions
- Brain Diseases
- Keywords
- MRI, Neuroradiology, minute-MRI, multi EPI-mix, Clinical Validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 7 May 2018 (actual)
- Study completion
- 7 May 2018 (actual)
- First posted
- 9 Nov 2017 (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 validity of a new minute-MRI sequence for neuroradiological evaluation in comparison to conventional MRI.
Detailed description
The study aims to assess the imaging quality 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 the AUC for diagnostic performance of minute MRI compared to conventional MRI.
Included patients are those with suspiscion of cerebral pathology.
Study participancts are investigated at 3T.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neuroradiological indication for brain MRI
Key inclusion criteria (1 listed)
- Neuroradiological MRI
Key exclusion criteria (1 listed)
- Aborted 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 |
|---|---|---|
| MRIMRI sequence without intravenous contrast | Diagnostic test | – |
Primary outcome
Diagnostic potential
Time frame: At MRI scan. Diagnostic accuracy to categorize scan as normal or abnormal on a five point Likert scale compared to abnormal/normal conventional MRI.
Diagnostic performance of lesion conspicuity of new MR sequence compared to conventional sequences
11 secondary outcomes
Lesion location determination
Time frame: At MRI scan
Lesion classification
Time frame: At MRI scan
Imaging quality
Time frame: At MRI scan
Diagnostic imaging quality
Time frame: At MRI scan
Anatomical conspicuity
Time frame: At MRI scan
Multifocality
Time frame: At MRI scan
Ability to rule out diseases
Time frame: At MRI scan
Lesion description
Time frame: At MRI scan
Diagnostic confidence
Time frame: At MRI scan
Brain coverage
Time frame: At MRI scan
Clinical diagnostic summay report
Time frame: At MRI scan
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 5 Oct 2018.
- Derived from this study: PubMed 30932287Delgado AF, Kits A, Bystam J, Kaijser M, Skorpil M, Sprenger T, Skare S. Diagnostic performance of a new multicontrast one-minute full brain exam (EPIMix) in neuroradiology: A prospective study. J Magn Reson Imaging. 2019 Dec;50(6):1824-1833. doi: 10.1002/jmri.26742. Epub 2019 Apr 1.
- Individual participant dataSharing planned: Undecided
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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.
Anna Falk Delgado, MD, PhD principal investigator
Clinical Neuroscience
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 1 inclusion and 1 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 5 Oct 2018. 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?
Diagnostic potential (time frame: At MRI scan. Diagnostic accuracy to categorize scan as normal or abnormal on a five point Likert scale compared to abnormal/normal conventional MRI.). 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 NCT03338270, 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 5 Oct 2018.