IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success

Обзор

Several clinical trials on genicular artery embolization (GAE) show significant clinical benefit for the majority of patients. However, a proportion of patients do not benefit from GAE, and responses vary across individual patients. Changes in metabolic activity on non-invasive imaging may correlate with improvement in symptoms of knee osteoarthritis. This study will assess changes in metabolic uptake on a hybrid positron emission tomography/magnetic resonance imaging (PET/MRI) system in subjects undergoing GAE.

Вмешательства

• Устройство Embolization
  Genicular artery embolization

Первичные конечные точки

• Compare metabolic activity [Срок оценки: Screening, Month 6]

Вторичные конечные точки (6)

• Associate changes in metabolic activity detected by PET [Срок оценки: Screening, Month 6]
• Assess osseous metabolic abnormalities correlation with osseous abnormalities and cartilage degeneration [Срок оценки: Screening, Month 6]
• Safety of GAE [Срок оценки: Treatment, Month 3, Month 6, Month 12]
• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Treatment Efficacy [Срок оценки: Screen, Month 3, Month 6, Month 12]
• Change From Baseline in Visual Analog Scale (VAS) as a Measure of Treatment Efficacy [Срок оценки: Screen, Month 3, Month 6, Month 12]
• Assess KOOS5 [Срок оценки: Screen, Month 3, Month 6, Month 12]

Критерии участия

Критерии включения

• Provided informed consent
• Age ≥ 40 years
• Ineligibility for or refusal of surgical management
• Moderate-severe knee pain as determined by visual analog scale > 5 out of 10
• Osteoarthritis based on X-ray. Kellgren-Lawrence score > 2 based on radiograph completed within 3 months of procedure date
• Resistant/failed some form of conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection/hyaluronic acid joint injection) for at least 3 months
• Able to comply with all treatments and protocol follow-up visits

Критерии исключения

• Mild knee pain as determined by visual analog scale < 5 out of 10
• OA on knee radiograph resulting in greater than 20 degree varus or valgus angulation
• Moderate loss of kidney function, define as estimated glomerular filtration rate of less than 45 mL/min.
• Significant arterial atherosclerosis that would limit selective angiography
• History of fibromyalgia, autoimmune, or inflammatory disorder
• History of any lumbar spine surgery, spine injections, or radicular pain in the extremity believed to originate from the spine
• Allergy to iodinated contrast agents
• Active infection or malignancy
• Recent (within 12 months) or active cigarette use
• Prior total or partial knee replacement in the subject knee
• Active pregnancy
• Uncorrectable bleeding diathesis
• Presence of pacemakers, aneurysm clips, neurostimulators, or any other metal implant not compatible with PET/MRI

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• University of California, Los Angeles — Los Angeles

Публикации

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• Bagla S, Piechowiak R, Hartman T, Orlando J, Del Gaizo D, Isaacson A. Genicular Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis. J Vasc Interv Radiol. 2020 Jul;31(7):1096-1102. doi: 10.1016/j.jvir.2019.09.018. Epub 2019 Dec 16. PMID 31837946
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Идентификаторы

NCT: NCT07494838 · 25-2531

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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