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

2. september 2026 oppdatert av: Henric Ryden, Region Stockholm

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

11

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sverige
      • Stockholm, Sverige
        • Karolinska Universitetssjukhuset

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Diagnostisk 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
MRI Acquisition Time
Tidsramme: 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.
From start to completion of each MRI acquisition used for the scan-time comparison, assessed up to 1 day.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
T2-FLAIR Relative Diagnostic Image Quality Score on a 5-Point Preference Scale
Tidsramme: At image review after the MRI examination, up to 12 months after enrollment
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
Tidsramme: At image review after the MRI examination, up to 12 months after enrollment.
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
Tidsramme: After image processing and analysis, up to 12 months after enrollment
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
Tidsramme: After image processing and analysis, up to 12 months after enrollment
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Region Stockholm

Etterforskere

  • Hovedetterforsker: Karl Henric Rydén, PhD, Karolinska University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. august 2026

Primær fullføring (Faktiske)

31. august 2026

Studiet fullført (Faktiske)

31. august 2026

Datoer for studieregistrering

Først innsendt

23. juni 2026

Først innsendt som oppfylte QC-kriteriene

1. juli 2026

Først lagt ut (Faktiske)

7. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • K 2026-6150
  • 2026-01765-01 (Annen identifikator: Swedish Ethical Review Authority)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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