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临床试验/NCT02022319
NCT02022319已完成不适用

Intra- and Inter-observer Variation of Thyroid Shear Wave Elastography - a Variability Study

University of Aarhus1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2013年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Elasticity index

研究概览

简要总结

Background: The main goal of diagnosing thyroid nodules is to differentiate the few malignant from the large background of benign lesion. Currently available pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic surgery is necessary. Therefore there is a need to develope the available diagnostic tools for the pre-operative diagnostic work-up of thyroid nodules.

The study will investigate a novel ultrasonographic technique called Shear Wave Elastography (SWE) in the pre-operative evaluation of thyroid nodules.

Hypothesis:

  1. SWE is a precise tool for evaluation of thyroid nodules in terms of inter- and intra-observer reliability and day-to-day variation.

The study will be conducted as part of a larger PhD study, and an evaluation of the diagnostic value of thyroid SWE will be evaluated in a larger study.

Perspectives:

An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the economic and surgical resources.

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

  • •patients with a thyroid nodule ≥1 cm in largest dimension (solitary or dominating nodule in multinodular goiter),
  • •Patients undergoing thyroid surgery.

排除标准

  • •Nodules located in the isthmus of the thyroid

研究组 & 干预措施

Shear Wave Elastography

Other

All included patients undergo a supplementary Shear Wave Elastographic scan

干预措施: Ultrasonographic Shear Wave Elastography (Device)

结局指标

主要结局

Elasticity index

时间窗: Repeat measures obtained on the same day (ten minutes to one hour between measurements), and measures obtained on a different day (one day to several weeks).

Elasticity Index is obtained by ultrasonographic Shear Wave Elastography performed by two investigators on the same day. The inter- and intra-observer variation and day-to-day variation is calculated

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

Kristine Zøylner Rubeck

MD

University of Aarhus

研究点 (1)

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