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临床试验/NCT04312646
NCT04312646Unknown不适用

Added Value of Ultrasound Elasatography in Characterization of Thyroid Nodules

Assiut University0 个研究点目标入组 50 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
To evaluate the role of Elastography in differentiation between benign and malignant thyroid nodules

研究概览

简要总结

Thyroid nodules are a common finding in the general population,however, they are mostly unpalpable and usually discovered either during neck ultrasound (US) examination or by pathological examination at autopsy. They are found in about 8% of adults. Most thyroid nodules ''incidentalomas" are benign, however 7% may be malignant. Early detection of thyroid cancer helps in early treatment and better survival US is an accurate method for detection of thyroid nodules; however, US has a low accuracy in differentiating between benign from malignant thyroid nodules . US could suggest a malignancy likelihood criteria of a thyroid nodule, such as hypoechogenicity, increased intranodular vascularity, irregular margins, microcalcifications, absent halo, and a taller-than-wide shape measured in the transverse dimension.

详细描述

US elastography has been used to detect the nature of thyroid nodules, by measuring the tissue stiffness non invasively. It depends on tissue deformation strain that is caused by external compression.it is complementary to gray scale findings particularly in nodules with indeterminate US findings, also US elastography could be used to guide the follow up of leisons diagnosed as benign at ( FNA) fine needle aspiration .

There are two main thyroid elastography methods in clinical practice: strain elastography (SE) and shear-wave elastography (SWE) .

Elastography methods can be classified into different variants based on the excitation method (external force, internal force, and acoustic radiation force [ARF]), and how stiffness is expressed . (A) strain elastography . SE reqires mechanical stress, which results in axial displacement of the tissue Tissue deformation from the stress is measured and visualized on a screen. The main limitations of SE are operator dependence for the angle, strength, and duration of compression.

(B) shear wave elastography . The acoustic pulses from the probe stimulate the target tissue, creating a shear wave (SW) traveling perpendicular to the conventional US waves. SWs are the transverse components of particle displacement that are rapidly attenuated by the tissue (1- 10 m/sec). This transverse component is tracked and measured as a numerical value corresponding to the shear-wave speed (SWS).This speed is closely related to the Young modulus formula, in which tissue elasticity can be assessed from the SW propagation.

US elastography is completely painless for the patient, and only requires a few extra minutes, with no separate patient preparation. US elastography has the potential to distinguish benign from malignant TNs, offering non-invasive complementary information to conventional US.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • solitary nodule on clinical or ultrasound examination

排除标准

  • Patients received any medical treatment or chemo or radiotherapy.
  • Patients underwent fine needle aspiration cytology or biopsy
  • Nodules with calcification and cystic changes

结局指标

主要结局

To evaluate the role of Elastography in differentiation between benign and malignant thyroid nodules

时间窗: one year

by its additional information over the classic gray scale and color Doppler ultrasound

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

Omima mahran hussein abd el wadod

principal investigator

Assiut University

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