oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 9
- 主要终点
- Assess whether the Optic Nerve Sheath Diameter (ONSD) measured by orbital ultrasound serves as an effective diagnostic marker for Giant Cell Arteritis (GCA)
研究概览
简要总结
The purpose of this study is to evaluate whether the measure of the optic nerve sheath is a reliable diagnostic marker for giant cell arteritis
详细描述
Giant Cell Arteritis (GCA) is a vasculitis affecting large and medium-sized vessels. It predominantly occurs in women, with a sex ratio of 3:1, and mainly affects individuals around 70 years of age. GCA is a rare condition, with an incidence of approximately 10 cases per 100,000 people in France.
Current recommendations suggest using imaging techniques and/or temporal artery biopsy (TAB) based on the clinical resources available. The key challenge in suspected cases of GCA is to establish a rapid diagnosis.
It is important to note that false-negative imaging results may occur if corticosteroid treatment is initiated prior to imaging: after 3 days for PET-CT, 5 to 7 days for Doppler ultrasound, and up to 14 days for TAB.
Diagnosing GCA is not always easy and depends on depends on the prompt performance of complementary examinations. Studies have shown that the optic nerve sheath is thickened on ultrasound in patients with GCA. In this context, the investigator aims to evaluate the measurement of the optic nerve sheath via ultrasound for diagnosing GCA. Ultrasound offers a faster, non-invasive, widely available, and cost-effective diagnostic tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with suspected GCA
- •Patient over 50 years
排除标准
- •Patient with history of GCA
- •Patient with a history of polymyalgia rheumatic (PMR) without initial PET scan
- •Patient with a history of retinal disease, demyelinating disease, or intracranial hypertension
- •Use of corticosteroids > 0.5mg/kg in the last 2 weeks
研究组 & 干预措施
Orbital ultrasounds
Orbital ultrasounds on patients suspected of GCA at the enrollment (M0) and at 6 months if the suspicion of GCA is confirmed after all the tests realized at the enrollment.
干预措施: orbital ultrasound (Diagnostic Test)
结局指标
主要结局
Assess whether the Optic Nerve Sheath Diameter (ONSD) measured by orbital ultrasound serves as an effective diagnostic marker for Giant Cell Arteritis (GCA)
时间窗: At the patient enrollment visit and at 6 months
Area under the ROC curve (AUC) of the optic nerve sheath measurements obtained by ultrasound during the enrollment phase, using the final clinical expert diagnosis at 6 months as the reference standard. The clinical expert's evaluation will be blinded to the optic nerve sheath measurements.
次要结局
- Exploratory evaluation of ONSD according to the presence or absence of extracranial GCA.(At the patient enrollment visit and at 6 months)
- Assess the feasibility of ultrasound as a diagnostic tool for GCA.(At the patient enrollment visit and at 6 months)
- Assess the reproducibility of the optic nerve sheath diameter (ONSD) measurements by ultrasound.(At the patient enrollment visit and at 6 months)
- Evaluate the diagnostic performance of ONSD in GCA.(At the patient enrollment visit and at 6 months)
- Study the evolution of ONSD under treatment between M0 and M6 in patients with GCA.(At the patient enrollment visit and at 6 months)
- Exploratory evaluation of ONSD based on the presence or absence of GCA with visual involvement.(At the patient enrollment visit and at 6 months)