Simultaneous T2-FLAIR and T1 Brain MRI With ENRAGED FLAIR in Multiple Sclerosis

NCT07687693 | Not Yet Recruiting

• 2 other identifiers: K 2026-61502026-01765-01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate a new brain MRI technique called ENRAGED FLAIR in patients with multiple sclerosis. MRI is central in the diagnosis and follow-up of multiple sclerosis because it can show inflammatory lesions in the brain. A standard MS brain MRI examination usually includes T2-FLAIR images, which are used to detect and assess MS lesions, and T1-weighted images, which provide anatomical information and help with interpretation of lesion location. These image types are usually acquired as separate scans. ENRAGED FLAIR is designed to acquire both T2-FLAIR and T1-weighted images during the same MRI sequence. The purpose of this study is to compare ENRAGED FLAIR with standard clinical MRI in patients with multiple sclerosis. Adult patients with multiple sclerosis who are already scheduled for a clinical brain MRI may be asked to participate. Participants will undergo one additional MRI sequence during the same visit. No extra contrast agent will be given, and no extra visit is required. The additional scan is expected to increase the examination time by about 5 to 10 minutes. The study will assess whether ENRAGED FLAIR provides image quality and MS lesion visualization comparable to standard MRI. If successful, this technique may help shorten future MRI examinations for patients with multiple sclerosis while preserving clinically useful image information.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; MS; MRI; Brain MRI; T2-FLAIR; Magnetic resonance imaging; T1-weighted MRI; 3D MRI; ENRAGED FLAIR; MRI sequence; Lesion detection; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• MRI Acquisition Time

  Acquisition time for ENRAGED FLAIR will be compared with the combined acquisition time of the corresponding standard clinical T2-FLAIR and T1-weighted MRI sequences in the same examination.

  From start to completion of each MRI acquisition used for the scan-time comparison, assessed up to 1 day.

Secondary Outcomes (4)

• T2-FLAIR Relative Diagnostic Image Quality Score on a 5-Point Preference Scale

  At image review after the MRI examination, up to 12 months after enrollment

• T1-Weighted Relative Diagnostic Image Quality Score on a 5-Point Preference Scale

  At image review after the MRI examination, up to 12 months after enrollment.

• MS Lesion Volume Agreement

  After image processing and analysis, up to 12 months after enrollment

• Automatic Brain Segmentation Agreement

  After image processing and analysis, up to 12 months after enrollment

Study Arms (1)

ENRAGED FLAIR MRI

EXPERIMENTAL

Participants undergo standard clinical brain MRI and one additional ENRAGED FLAIR MRI acquisition during the same examination. ENRAGED FLAIR images will be compared with standard clinical T2-FLAIR and T1-weighted images acquired in the same participant.

Diagnostic Test: ENRAGED FLAIR MRI

Interventions

ENRAGED FLAIR MRI DIAGNOSTIC_TEST

ENRAGED FLAIR is a combined MRI acquisition designed to generate both 3D T2-FLAIR and T1-weighted brain images from a single sequence. The additional sequence is acquired during the same clinical MRI examination and does not involve extra contrast agent or an additional study visit.

ENRAGED FLAIR MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, 18 years of age or older
• Diagnosis of multiple sclerosis
• Scheduled for a clinical brain MRI examination including T2-FLAIR and T1-weighted imaging
• Able to provide written informed consent

You may not qualify if:

• Age under 18 years
• Severe claustrophobia or inability to tolerate the additional MRI acquisition time
• Inability to provide written informed consent

Sponsors & Collaborators

• Region Stockholm: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Karl Henric Rydén, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl Henric Rydén, PhD

CONTACT

+46735056270; henric.ryden@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcome assessors performing image review will be masked to the acquisition method when feasible. Images will be reviewed in randomized order. Participants and MRI staff will not be masked because the ENRAGED FLAIR acquisition is added to the clinical MRI examination.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants undergo the same study procedure: standard clinical brain MRI and one additional ENRAGED FLAIR MRI acquisition during the same examination. Each participant serves as their own control for comparison between ENRAGED FLAIR and standard MRI.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share