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临床试验/NCT03700762
NCT03700762Unknown不适用

Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.

First People's Hospital of Hangzhou1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
The diagnostic value of UGSR in differentiating benign from malignant thyroid nodules.

研究概览

简要总结

According to the grades of echogenicity to evulated thyroid nodules is a subjective process and is thus influenced by the observer's judgement. The investigators first proposed the ultrasound gray-scale ratio (UGSR) to explore its efficacy for differentiating papillary thyroid microcarcinomas from small nodular goiters.

详细描述

Echogenicity is a common ultrasonic parameter to evaluate thyroid nodules. The echogenicity of the thyroid nodule was divided into 5 grades according to gray scale. Of the five categories, the diagnostic values of the hypoechoic and markedly hypoechoic categories have been widely accepted for thyroid malignant nodules. However, distinguishing between hypoechoic and markedly hypoechoic categories is a subjective process and is thus influenced by the observer's judgement. A more objective method should be proposed to differentiate papillary thyroid microcarcinoma(PTMC) from small nodular goiter(NG).

The investigators suspect the echo intensity of nodules could be reflected by values, as CT values reflecting the nodule density. The investigators first proposed the ultrasound gray-scale ratio (UGSR), namely, the ratio of lesion gray-scale value to surrounding normal thyroid tissue, and the previous study showed UGSR can better display the relationship of gray scale of PTMC or NG with surrounding normal thyroid tissue, and can make objective judgment of the nodules through quantitative results.

As the absolute ultrasound grayscale value is affected by the apparatus, scan gain, dynamic range, frequency, and operators. The investigators would collected different data acquired from different parameters to explore their potential relations.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients diagnosed as thyroid nodule.
  • homo-echogenicity of normal thyroid tissue.
  • able and willing to comply with all study requirements.

排除标准

  • nodules are mainly cystic or calcified.
  • pathology confirmed Hashimoto's thyroiditis.
  • unable or unwilling to comply with all study requirements.

结局指标

主要结局

The diagnostic value of UGSR in differentiating benign from malignant thyroid nodules.

时间窗: All the data will be uploaded in 1 year.

The accuracy, sensitivity and specificity of UGSR in differentiating benign from malignant thyroid nodules.

次要结局

  • The best UGSR in differentiating benign from malignant thyroid nodules.(All the data will be uploaded in 1 year.)

研究者

发起方
First People's Hospital of Hangzhou
申办方类型
Other
责任方
Sponsor

研究点 (1)

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