跳至主要内容
临床试验/NCT02678091
NCT02678091已完成不适用

Contribution of the Quantitative Analysis of the Ultrasound Exam With Doppler for the Etiological Diagnosis of Orbital Masses (PUCE)

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2016年6月30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
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

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

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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