- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07305948
Evaluation of a New MRI Technique to Reduce Breathing-Related Artifacts in Brain Imaging (DORK)
Prospective Evaluation of a Free Induction Decay (FID) Navigator-Based Off-Resonance Correction Method (DORK) for Improving High-Resolution 3D Echo Planar (EPI) Susceptibility-Weighted (SWI) Brain MRI
This study aims to improve the quality of brain magnetic resonance imaging (MRI) scans by testing a new imaging method that reduces distortions caused by breathing. During respiration, small movements of the chest and diaphragm can lead to subtle changes in the magnetic field within the head. These changes can introduce artifacts in certain MRI techniques, particularly susceptibility-weighted imaging (SWI), which is used to visualize veins, small hemorrhages, and iron deposits.
The investigated method measures breathing-related magnetic field variations during MRI acquisition using two very short navigator signals, referred to as free induction decay (FID) navigators. These signals are used to perform dynamic off-resonance correction during image reconstruction, reducing image blurring and distortion. The method does not increase scan time and does not affect standard clinical imaging.
In this study, patients scheduled for routine clinical brain MRI are asked to provide informed consent for use of their raw MRI data for research purposes. For each participant, two sets of SWI images are generated from the same acquisition: one using standard reconstruction and one using the free induction decay navigator-based dynamic off-resonance correction method (FID-DORK). The objective is to assess whether the corrected images provide improved image quality and diagnostic reliability.
The study includes adult patients undergoing routine clinical MRI at Karolinska University Hospital. Image quality is evaluated using both visual assessment by neuroradiologists and quantitative measures of image variation. No additional imaging procedures, contrast agents, or scan time are required. All research data are pseudonymized prior to analysis.
The hypothesis is that the dual free induction decay navigator-based correction method (FID-DORK) improves the diagnostic quality of high-resolution three-dimensional echo-planar imaging susceptibility-weighted imaging brain MRI by reducing breathing-related artifacts.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ola Norbeck, PhD
- Phone Number: +46735670476
- Email: ola.norbeck@regionstockholm.se
Study Locations
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-
Solna
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Stockholm, Solna, Sweden, 171 76
- Recruiting
- Karolinska University Hospital
-
Contact:
- Ola Norbeck, PhD
- Phone Number: +46735670476
- Email: ola.norbeck@regionstockholm.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (18 years or older)
- Undergoing a routine clinical brain MRI at Karolinska University Hospital
- Able to understand the study information and provide written informed consent
- Sequence parameters and scan protocol compatible with the research acquisition (3D-EPI SWI)
Exclusion Criteria:
- Patients unable to give informed consent
- Standard contraindications to MRI (e.g., non-MRI safe implants, severe claustrophobia)
- Clinical conditions requiring urgent imaging where research consent is not feasible
- Significant motion or incomplete scans preventing creation of research images (rare)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients Undergoing Routine Clinical Brain MRI
|
This intervention consists of a modified magnetic resonance imaging (MRI) acquisition and reconstruction method used during routine clinical brain imaging.
The method adds two very short free-induction-decay (FID) navigator signals to each repetition of a high-resolution 3D echo planar imaging (EPI) susceptibility-weighted imaging (SWI) sequence.
These navigator signals measure breathing-related magnetic field changes, which are then used to perform dynamic off-resonance correction (DORK) during image reconstruction.
The modified sequence does not change the clinical scan time or affect patient care.
For each participant, both uncorrected and corrected SWI images are generated from the same raw data.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Susceptibility-Weighted Imaging Image Quality With and Without Free Induction Decay Navigator-Based Dynamic Off-Resonance Correction (FID-DORK)
Time Frame: Periprocedural (during the clinical brain MRI examination)
|
Image quality of susceptibility-weighted imaging scans reconstructed with and without free induction decay navigator-based dynamic off-resonance correction is compared.
Image quality is assessed using visual ratings by neuroradiologists and quantitative measures of image variation.
Differences in image quality between corrected and uncorrected reconstructions are evaluated.
|
Periprocedural (during the clinical brain MRI examination)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K2025-9116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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