Prediction of Risk of Vascular Structural Damage in Patients With Large Vessel Vasculitis (LVV) Based on PET/MRA Image Evaluation System

Официальное название

A Prospective, Observational Study on Prediction of Risk of Vascular Structural Damage in Patients With Large Vessel Vasculitis(LVV) Based on PET/MRA Image Evaluation System

Обзор

Large vessel vasculitis (LVV) causes vascular inflammation, leading to serious complications such as aneurysm formation and stroke. It is difficult to identify the inflammation of the vessel wall by the current imaging methods, thus affecting the timing of treatment and selection of treatment options. Improved examination methods to determine disease activity are highly needed to guide treatment.

Подробное описание

This study was designed to assess vascular wall inflammation in patients with large vessel vasculitis by positron emission tomography and magnetic resonance imaging (PET/MRA). The study has a 12-month follow-up period. After completing the baseline clinical assessment, laboratory test and PET/MRA assessment, the intervention protocol will be determined by clinicians. The patients will visit the clinic every 1-2 months according to their specific conditions. Clinical assessment, laboratory test and PET/MRA re-examination will be completed at 6 and 12 months after treatment.

Вмешательства

• Препарат glucocorticoid, immunosuppressants, targeted therapy
  Drug intervention protocol will be determined by clinicians

Первичные конечные точки

• Vascular structural progression [Срок оценки: 12 months]

Вторичные конечные точки (2)

• SUV max [Срок оценки: 12 months]
• TBA [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Clinically suspected or confirmed LVV and willing to undergo PET/MRA
• Compliance with long-term follow-up
• Sign informed consent.

Критерии исключения

• Patients with other serious cardiovascular and cerebrovascular diseases, malignant tumors, infectious diseases, severe renal insufficiency.
• Severe mental disorders, severe claustrophobia unable to cooperate with the examination.
• Patients equipped with cardiac pacemaker, artificial heart valve, ferromagnetic vascular clamp after vascular surgery, aneurysm clamp, artificial cochlea, insulin pump and other drug dosage control devices, steel nail plate and other metal internal fixation, artificial joint, electronic eye, artificial eye.
• Allergic to contrast medium.
• Pregnant or lactating women.

Withdrawal criteria:

• Any exclusion criteria emerged during patient follow-up.
• Voluntarily withdrew from the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Department of Rheumatology and Immunology, Jiangsu Province Hospital, Nanjing Medical Univ — Нанкин

Публикации

• Martinez-Moller A, Nekolla SG. Attenuation correction for PET/MR: problems, novel approaches and practical solutions. Z Med Phys. 2012 Dec;22(4):299-310. doi: 10.1016/j.zemedi.2012.08.003. Epub 2012 Aug 25. PMID 22925653
• Kostakoglu L, Chauvie S. Metabolic Tumor Volume Metrics in Lymphoma. Semin Nucl Med. 2018 Jan;48(1):50-66. doi: 10.1053/j.semnuclmed.2017.09.005. PMID 29195618

Идентификаторы

NCT: NCT06824714 · 2024-SR-693

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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