NCT07305948

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

November 27, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 2, 2026

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

November 27, 2025

Last Update Submit

January 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Susceptibility-Weighted Imaging Image Quality With and Without Free Induction Decay Navigator-Based Dynamic Off-Resonance Correction (FID-DORK)

    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)

Study Arms (1)

Patients Undergoing Routine Clinical Brain MRI

Diagnostic Test: Dual Free Induction Decay (FID) Navigator Off-Resonance Corrected (DORK) 3D Susceptibility Weighted (SWI) Echo Planar Imaging (EPI)

Interventions

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.

Patients Undergoing Routine Clinical Brain MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be selected from adult patients referred for routine clinical brain MRI examinations at Karolinska University Hospital in Stockholm, Sweden. These individuals represent a typical clinical population undergoing MRI for a wide range of neurological indications, including tumors, vascular disorders, inflammatory conditions, and other brain diseases. Only patients scheduled for standard-of-care brain MRI that includes a susceptibility-weighted sequence (SWI) will be approached for participation.

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Solna, 171 76, Sweden

RECRUITING

MeSH Terms

Conditions

Brain Diseases

Interventions

Echo-Planar Imaging

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2025

First Posted

December 26, 2025

Study Start

January 5, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

February 2, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations