MRI-Based Lesion Differentiation in Older Patients With Multiple Sclerosis
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Multiple Sclerosis (MS), Cerebral Small Vessel Diseases. Базовые параметры: 50 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Норвегия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Quantitative Susceptibility Mapping for Lesion Differentiation in Aging Multiple Sclerosis
Обзор
This study investigates whether an advanced MRI technique called Quantitative Susceptibility Mapping (QSM) can improve the differentiation of white matter lesions in people aged 50-70 years with multiple sclerosis (MS). In older individuals with MS, white matter changes seen on MRI may be related to MS or to other types of white matter changes, most commonly age-related changes or chronic small vessel disease. These conditions can appear similar on conventional MRI scans, making interpretation challenging. Participants will undergo routine clinical MRI, including a short additional QSM sequence, as well as brief cognitive and physical assessments. A comparison group with cerebral small vessel disease will also be included. The goal of the study is to determine whether QSM can provide more precise lesion characterization and support more accurate clinical interpretation of MRI findings in older patients with MS.
Подробное описание
Magnetic resonance imaging (MRI) is central to the diagnosis and monitoring of multiple sclerosis (MS). In individuals above 50 years of age, interpretation of white matter lesions becomes increasingly complex because lesions visible on conventional T2-weighted and FLAIR MRI may reflect MS-related demyelination, chronic cerebral small vessel disease (cSVD), or nonspecific age-related white matter changes. Conventional MRI has limited specificity in differentiating between these entities, which may complicate assessment of disease activity and progression.
Quantitative Susceptibility Mapping (QSM) is an advanced MRI technique that quantifies tissue magnetic susceptibility and provides complementary information to conventional imaging. Differences in susceptibility characteristics may reflect underlying tissue composition and microstructural properties, potentially allowing improved differentiation between demyelinating and vascular white matter lesions.
This prospective observational cohort study includes individuals aged 50-70 years with established MS undergoing routine clinical MRI follow-up, as well as an age-comparable cohort with clinical and radiological evidence of cSVD. Participants with MS will undergo longitudinal follow-up through routine clinical MRI and clinical assessments, whereas participants in the cSVD cohort will undergo a single study visit including MRI and standardized clinical testing. MRI examinations include standard clinical sequences with the addition of a short QSM acquisition. Clinical assessment includes brief standardized measures of cognitive processing speed, executive function, and physical function performed in conjunction with clinical visits.
Imaging analyses will focus on lesion-level and participant-level susceptibility characteristics and their distribution patterns across cohorts. Associations between QSM-derived measures and clinical function will be explored. The study is designed to evaluate the diagnostic utility and clinical relevance of QSM-based lesion characterization in older individuals with MS.
Первичные конечные точки
- Lesion-Level Quantitative Susceptibility (ppb) Within T2 FLAIR Hyperintense White Matter Lesions at Baseline [Срок оценки: Baseline MRI (single MRI session for both cohorts)]
Вторичные конечные точки (4)
- Change From Baseline in Mean Lesion-Level Quantitative Susceptibility (ppb) Within T2 FLAIR Hyperintense White Matter Lesions in the MS Cohort [Срок оценки: From baseline through December 2030]
- Association Between QSM-Derived Lesion Burden and Cognitive Composite z-Score [Срок оценки: Baseline; repeated assessments in the MS cohort through December 2030]
- Association Between QSM-Derived Lesion Burden and Physical Function Composite z-Score [Срок оценки: Baseline; repeated assessments through December 2030]
- Association Between QSM-Derived Lesion Burden and Change From Baseline in Expanded Disability Status Scale (EDSS) Score [Срок оценки: From baseline through December 2030]
Критерии участия
Inclusion Criteria Multiple Sclerosis (MS) cohort (AgeMS):
- Age 50-70 years
- Clinically confirmed diagnosis of multiple sclerosis
- Participation in the AgeMS study at Oslo University Hospital
Inclusion Criteria Cerebral Small Vessel Disease (cSVD) control cohort:
- Age 50-80 years
- Radiological evidence of hypertensive small vessel disease on MRI
- Good clinical recovery following transient ischemic attack (TIA), minor stroke, or stroke mimic diagnosis
Exclusion Criteria Multiple Sclerosis (MS) cohort:
- MRI contraindications
- Severe psychiatric comorbidity
- Major functional disability unrelated to MS or CSVD
Exclusion Criteria Cerebral Small Vessel Disease (cSVD) control cohort:
- MRI contraindications
- Probable or definite cerebral amyloid angiopathy according to Boston criteria 2.0
- Genetic or inflammatory vasculopathies
- Persistent neurological deficits
- Severe psychiatric comorbidity
- Major functional disability unrelated to CSVD
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Норвегия · 1 центр
- Oslo University Hospital — Oslo
Идентификаторы
NCT: NCT07444047 · 952017 · OUS Project ID 25/27215