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临床试验/NCT05000138
NCT05000138已完成不适用

FDG Digital PET/CT as First Line Investigation for Giant Cell Arteritis

Jewish General Hospital5 个研究点 分布在 3 个国家目标入组 92 人开始时间: 2022年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
5
主要终点
Diagnostic Performance

研究概览

简要总结

Giant cell arteritis (GCA) causes inflammation of the arteries and can lead to serious complications such as blindness, necessitating rapid diagnosis and treatment. Although older technology non-digital PET/CT scans are routinely used for the diagnosis of GCA in large arteries, they have not been able to reliably detect inflammation of the small arteries responsible for blindness. Recent technological advances have enabled PET/CT imaging of millimetric disease in the body, which are now able to resolve small arteries. In the proposed research study, patients who are suspected by their doctors to have GCA will undergo an ultrasound of the temporal arteries, and digital PET/CT scan after injection of radioactive glucose. Digital PET/CT scans will be interpreted for the presence of abnormal uptake in the large and small arteries, as well as for the presence of other causes of the patient's symptoms. The diagnostic accuracy of PET/CT and ultrasound will be evaluated with respect to an expert panel diagnosis of giant cell arteritis and compared. Results will be adjusted for lack of a perfect reference test using advanced statistics. The goal will be to see if digital PET/CT can become a single, integrated test to diagnose this disease.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 50 years, capable and willing to provide informed consent and can tolerate PET/CT.
  • ESR ≥ 50 mm/h and/or CRP ≥ 10mg/L within 1 week of PET/CT referral.
  • New suspected giant cell arteritis according to at least one of the following criteria:
  • Cranial GCA symptoms (new-onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, masseter pain on prolonged mastication) PMR symptoms: shoulder and/or hip girdle pain associated with inflammatory stiffness.
  • Suspected large-vessel vasculitis based on angiography, MRA, or CTA.

排除标准

  • Initiation of corticosteroid or immunosuppressive therapy >4 days before PET/CT.
  • Prior TAB or treated GCA with suspected relapse.
  • Non-fasting or hyperglycemia (>11.1 mmol/L) resulting in altered FDG biodistribution.

结局指标

主要结局

Diagnostic Performance

时间窗: 2 years

of Digital PET/CT and DUS for the diagnosis of GCA

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gad Abikhzer

Associate Professor

Jewish General Hospital

研究点 (5)

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