Contribution of the Quantitative Analysis of the Ultrasound Exam With Doppler for the Etiological Diagnosis of Orbital Masses (PUCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Sensitivity, expressed as a percentage, of the ultrasound exam with Doppler, the pathological exam being the gold standard
研究概览
简要总结
Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation.
Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers.
The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients.
Quantitative analysis of the ultrasound exam with doppler of those masses could identify diagnostic criteria, especially for the lacrimal gland, easily explorable.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient aged 18 years or more
- •with an orbital mass for which a biopsy and/or a surgical removal is planned
- •before surgery or biopsy
排除标准
- •pregnancy
- •breast feeding
- •patient under a legal protection procedure
- •patient denying to participate to the study
- •lack of affiliation to a social security system
结局指标
主要结局
Sensitivity, expressed as a percentage, of the ultrasound exam with Doppler, the pathological exam being the gold standard
时间窗: One month
Specificity, expressed as a percentage, of the ultrasound exam with Doppler, the pathological exam being the gold standard
时间窗: One month
次要结局
未报告次要终点
