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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Stockholm, Szwecja
- Karolinska Universitetssjukhuset
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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MRI Acquisition Time
Ramy czasowe: From start to completion of each MRI acquisition used for the scan-time comparison, assessed up to 1 day.
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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.
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From start to completion of each MRI acquisition used for the scan-time comparison, assessed up to 1 day.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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T2-FLAIR Relative Diagnostic Image Quality Score on a 5-Point Preference Scale
Ramy czasowe: At image review after the MRI examination, up to 12 months after enrollment
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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.
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At image review after the MRI examination, up to 12 months after enrollment
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T1-Weighted Relative Diagnostic Image Quality Score on a 5-Point Preference Scale
Ramy czasowe: At image review after the MRI examination, up to 12 months after enrollment.
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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.
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At image review after the MRI examination, up to 12 months after enrollment.
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MS Lesion Volume Agreement
Ramy czasowe: After image processing and analysis, up to 12 months after enrollment
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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.
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After image processing and analysis, up to 12 months after enrollment
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Automatic Brain Segmentation Agreement
Ramy czasowe: After image processing and analysis, up to 12 months after enrollment
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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.
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After image processing and analysis, up to 12 months after enrollment
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Karl Henric Rydén, PhD, Karolinska University Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- K 2026-6150
- 2026-01765-01 (Inny identyfikator: Swedish Ethical Review Authority)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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