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Идёт набор NCT07010484

Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica

— Наблюдательное Polymyalgia Rheumatica (PMR)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PET/MRI, PET/CT with 18-FDG.
Кому может быть актуально
Состояния в реестре: Polymyalgia Rheumatica (PMR). Базовые параметры: от 50 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
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Polymyalgia rheumatica (PMR) is the most common chronic inflammatory rheumatic disease among the elderly and is characterized by proximal extremity pain and fatigue. Treatment with prednisolone carries several significant adverse effects, and it is therefore essential to avoid unnecessary treatment. However, clinical diagnosis and even imaging such as positron emission tomography and computed tomography (PET/CT) has low diagnostic accuracy, which decrease after start of prednisolone. The purpose is to evaluate a new method to diagnose PMR with PET/CT using magnetic resonance imaging (MRI) for informing the interpretation of PET in 111 patients suspected of PMR at baseline and after 8 weeks prednisolone treatment. In addition, a treatment initiation strategy guided by clinical diagnosis combined with PET will be evaluated in 100 patients with newly diagnosed PMR.

Вмешательства

  • Диагностический тест PET/MRI
    PET/MRI at baseline and week 8
  • Диагностический тест PET/CT with 18-FDG
    PET/CT in patients not receiving PET/MRI

Первичные конечные точки

  • Clinical diagnosis of PMR after 1 year and a positive baseline [18F]FDG-PET scan, with MRI findings used to support interpretation of the PET evaluation. [Срок оценки: Baseline]
  • A clinical diagnosis of PMR at baseline and a negative PET not requiring glucocorticoids for more than 3 months during the first year. [Срок оценки: Baseline to 1 year]
Вторичные конечные точки (12)
  • Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI at baseline. [Срок оценки: Baseline]
  • Clinical diagnosis of PMR after 1 year and a positive MRI at baseline. [Срок оценки: Baseline]
  • Circular, focal, and/or cylindrical [18F]FDG-uptake patterns associated to synovitis, bursitis, and tendinitis/tenosynovitis in the shoulders and hips on MRI or ultrasound. [Срок оценки: Baseline]
  • Clinical diagnosis of PMR after 1 year and synovitis, bursitis, and tendinitis/tenosynovits in the shoulders and hips. [Срок оценки: Baseline]
  • Clinical diagnosis of PMR after 1 year and extra-capsular PMR diagnosed using [18F]FDG-PET/MRI. [Срок оценки: Baseline]
  • Extra-capsular PMR and remission after 2 or 4 weeks. [Срок оценки: Baseline to 4 weeks]
  • Extra-capsular PMR with relapse and remaining in prednisolone treatment within the first year, first 3 years, and first 5 years. [Срок оценки: Baseline to 5 years]
  • Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/CT after 8 weeks of prednisolone treatment, with MRI findings used to support PET interpretation. [Срок оценки: 8 weeks]
  • Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI after 8 weeks of prednisolone treatment. [Срок оценки: 8 weeks]
  • Clinical diagnosis of PMR after 1 year and a positive MRI after 8 weeks of prednisolone treatment. [Срок оценки: 8 weeks]
  • Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on [18F]FDG-PET/MRI findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years. [Срок оценки: Baseline to 5 years]
  • Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on MRI findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years. [Срок оценки: Baseline to 5 years]

Критерии участия

Критерии включения

  • Patients suspected of PMR seen at the Department of Rheumatology/internal medicine in Aarhus, Silkeborg, Horsens, Gødstrup, Randers, and Svendborg.
  • Age above 50.
  • Proximal extremity pain.

Критерии исключения

  • Oral, intravenous, intra-articular or intramuscular glucocorticoids within the last 2 months.
  • Previous prednisolone treatment for GCA/PMR.
  • Unable to give consent.
  • Proximal extremity pain duration for more than one year.
  • Symptoms of GCA (headache, scalp tenderness, jaw or tongue claudication, vision disturbances attributable to GCA, limb claudication).
  • Active malignant cancers within the last 5 years (except basal cell carcinoma).
  • Other known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritis, gout).
  • Uncontrolled diseases (e.g. severe active asthma, cardiac disease with NYHA class IV)
  • For MRI: Implants contraindicating MRI and BMI>150 kg.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Дания · 7 центров
  • Aarhus University Hospital — Aarhus
  • Gødstrup Hospital — Gødstrup
  • Horsens Regional Hospital — Horsens
  • Odense University Hospital — Odense
  • Randers Regional Hospital — Randers
  • Central Jutland Regional Hospital — Silkeborg
  • Svendborg Hospital — Svendborg

Идентификаторы

NCT: NCT07010484 · 1-10-72-69-25 · NNF24OC0094827

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗