Multiple SclerosisENRAGED FLAIRNCT07687693
Simultaneous T2-FLAIR and T1 Brain MRI With ENRAGED FLAIR in Multiple Sclerosis
A study testing ENRAGED FLAIR MRI in people with Multiple Sclerosis, run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ENRAGED FLAIR MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- 10 Aug 2026to 31 Aug 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age under 18 years
- Severe claustrophobia or inability to tolerate the additional MRI acquisition time
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- ENRAGED FLAIR MRI
- Keywords
- Multiple sclerosis, MS, MRI, Brain MRI, T2-FLAIR, Magnetic resonance imaging, T1-weighted MRI, 3D MRI, ENRAGED FLAIR, MRI sequence, Lesion detection, Neuroimaging
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENRAGED FLAIR MRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ENRAGED FLAIR MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After image processing and analysis, up to 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start10 Aug 2026
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Henric Ryden, Region Stockholm
- Investigators
- Karl Henric Rydén, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687693
- Sponsor's protocol ID
- K 2026-6150
- Other IDs
- 2026-01765-01
- Acronym
- ENRAGED FLAIR
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Combined MR Sequence for Simultaneous T2- and T1-Weighted Brain Imaging in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07687693
- Acronym / sponsor ID
- ENRAGED FLAIR / K 2026-6150
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, MS, MRI, Brain MRI, T2-FLAIR, Magnetic resonance imaging, T1-weighted MRI, 3D MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 7 Jul 2026 (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 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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ENRAGED FLAIR MRI | Experimental | Diagnostic Test: ENRAGED FLAIR MRIParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age under 18 years
- Severe claustrophobia or inability to tolerate the additional MRI acquisition time
- Inability to provide written informed consent
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 |
|---|---|---|
| ENRAGED FLAIR MRIENRAGED 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. | Diagnostic test | ENRAGED FLAIR MRI |
Primary outcome
MRI Acquisition Time
Time frame: From start to completion of each MRI acquisition used for the scan-time comparison, assessed up to 1 day.
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.
4 secondary outcomes
T2-FLAIR Relative Diagnostic Image Quality Score on a 5-Point Preference Scale
Time frame: 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
Time frame: At image review after the MRI examination, up to 12 months after enrollment.
MS Lesion Volume Agreement
Time frame: After image processing and analysis, up to 12 months after enrollment
Automatic Brain Segmentation Agreement
Time frame: After image processing and analysis, up to 12 months after enrollment
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 3 Sep 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
Karl Henric Rydén, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENRAGED FLAIR MRI in people with Multiple Sclerosis, run by Region Stockholm 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 4 inclusion and 3 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 3 Sep 2026. 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?
MRI Acquisition Time (time frame: From start to completion of each MRI acquisition used for the scan-time comparison, assessed up to 1 day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.