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

Evaluation of a Combined MR Sequence for Simultaneous T2- and T1-Weighted Brain Imaging in Multiple Sclerosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Diagnostic test: ENRAGED FLAIR MRI

Detailed Description

Multiple sclerosis (MS) is commonly monitored with brain MRI. T2-FLAIR imaging is central for detecting and following MS lesions, while T1-weighted imaging provides anatomical information that supports lesion localization and interpretation. In routine clinical MRI, these contrasts are usually acquired as separate sequences, which increases examination time.

ENRAGED FLAIR is a combined MRI acquisition designed to generate both 3D T2-FLAIR and T1-weighted brain images from a single sequence. The method uses otherwise unused recovery time in a FLAIR acquisition to acquire T1-weighted data. This may improve scan efficiency while preserving the clinically important information from both contrasts.

This study is a prospective intra-individual comparison in adult patients with MS undergoing clinically indicated brain MRI. Each participant will undergo standard clinical MRI sequences and one additional ENRAGED FLAIR acquisition during the same examination. No additional contrast agent or study visit is required.

Images from ENRAGED FLAIR will be compared with standard clinical T2-FLAIR and T1-weighted images. The evaluation will focus on MS lesion visualization, diagnostic image quality, and whether the simultaneously acquired T1-weighted images provide sufficient anatomical information for interpretation. Because each participant undergoes both standard MRI and ENRAGED FLAIR, each participant serves as their own control.

The study is intended to determine whether ENRAGED FLAIR can provide image quality comparable to standard MRI in MS while potentially enabling shorter future brain MRI protocols.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karl Henric Rydén, PhD; Phone Number: +46735056270; Email: henric.ryden@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ENRAGED FLAIR MRI; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
T2-FLAIR Relative Diagnostic Image Quality Score on a 5-Point Preference Scale	Blinded neuroradiologists will compare ENRAGED FLAIR-derived T2-FLAIR images with standard clinical T2-FLAIR images for MS lesion assessment and routine clinical interpretation using a 5-point relative diagnostic image quality scale. Scores range from 1 to 5: 1 = standard clinical T2-FLAIR strongly preferred, 2 = standard clinical T2-FLAIR slightly preferred, 3 = no preference/equivalent diagnostic quality, 4 = ENRAGED FLAIR-derived T2-FLAIR slightly preferred, and 5 = ENRAGED FLAIR-derived T2-FLAIR strongly preferred. Higher scores favor ENRAGED FLAIR.	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	Blinded neuroradiologists will compare ENRAGED FLAIR-derived T1-weighted images with standard clinical T1-weighted images for anatomical interpretability and support of MS lesion localization using a 5-point relative diagnostic image quality scale. Scores range from 1 to 5: 1 = standard clinical T1-weighted image strongly preferred, 2 = standard clinical T1-weighted image slightly preferred, 3 = no preference/equivalent diagnostic quality, 4 = ENRAGED FLAIR-derived T1-weighted image slightly preferred, and 5 = ENRAGED FLAIR-derived T1-weighted image strongly preferred. Higher scores favor ENRAGED FLAIR.	At image review after the MRI examination, up to 12 months after enrollment.
MS Lesion Volume Agreement	MS lesion volumes derived from ENRAGED FLAIR images will be compared with lesion volumes derived from standard clinical T2-FLAIR images using automated or semi-automated lesion segmentation.	After image processing and analysis, up to 12 months after enrollment
Automatic Brain Segmentation Agreement	Brain tissue segmentation results derived from ENRAGED FLAIR images will be compared with segmentation results derived from standard clinical MRI images using automated brain segmentation software. Agreement will be assessed for relevant volumetric outputs used in MS image analysis.	After image processing and analysis, up to 12 months after enrollment

Collaborators and Investigators

• Sponsor: Region Stockholm
• Investigators: Principal Investigator: Karl Henric Rydén, PhD, Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: MRI; MS; Multiple sclerosis; Magnetic resonance imaging; Neuroimaging; Brain MRI; 3D MRI; MRI sequence; T2-FLAIR; T1-weighted MRI; ENRAGED FLAIR; Lesion detection
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: K 2026-6150; 2026-01765-01 (Other Identifier: Swedish Ethical Review Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study uses pseudonymized clinical MRI data and health-related information that are subject to ethical approval, GDPR, and institutional data protection requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No