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临床试验/NCT03102099
NCT03102099Unknown不适用

Application Value of Contrast-enhanced Ultrasound-guided Fine-needle Aspiration Biopsy in the Evaluation of Thyroid Nodules

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
The Bethesda System for Reporting Thyroid Cytology (TBSRTC)

研究概览

简要总结

To evaluate the application value of contrast-enhanced ultrasound in the diagnosis of thyroid nodules using fine needle aspiration.

详细描述

Thyroid nodules and thyroid cancer are common and frequently occurring diseases in China; Relevant researches reveal that the increase in the incidence of thyroid cancer is more prominent in China than that of overseas, the incidence of thyroid cancer in urban residents of Beijing increased from 1.55/100,000 in 1995 to 9.9/100,000 in 2010 (5.38 fold).

The rapid development of imaging techniques including ultrasound, CT and MRI had substantially increased the accuracy in the diagnosis of thyroid nodules, however the accuracy is still not up to 100% and a further aspiration biopsy is required. Therefore, ultrasound-guided percutaneous biopsy plays a critical role in the diagnosis of pathological lesions. Many guidelines deem fine needle aspiration (FNA) biopsy to be the most accurate and cost-effective examination method in the evaluation of thyroid nodules as it helps to reduce unnecessary thyroid nodule surgeries and it also helps the clinicians to determine the appropriate surgical treatment plan[1-4]. However according to literature reports, samples with insufficient quantity of cells can occur up to 10-15% of the cases, sometimes a second biopsy or a diagnostic operation needs to be performed[1,4].False negative results of FNA biopsy or a mismatch between ultrasound diagnosis and clinical diagnosis can occur due to a number of reasons such as the tumor being too big or too small, a poor location, presence of degenerative necrosis, inappropriate position of biopsy or be affected by the operator's experience etc.

Contrast-enhanced ultrasound (CEUS) is a new technology which is recently introduced into China, it has the ability to display the microvascular perfusion of the tissue under a low mechanical index. The serial real-time images obtained can be digitalized and dynamically stored. And this allows for retrospective analysis and also enables comparison to be made with other imaging techniques. CEUS can sensitively reflect the characteristics of blood supply and microcirculation at the site of the lesion.

Although CEUS-guided FNA of thyroid nodules has not yet been reported, a large number of studies have reported liver biopsy performed under the guidance of CEUS. Its efficacy in obtaining accurate diagnosis and in reducing the number of biopsies is clear when samples are taken from the area of rich blood supply.

Metabolic-active areas within the malignant tumor, or areas of degeneration or necrosis and also the detection of small tumors can be confirmed through the use of CEUS. Aspiration biopsy when performed under the guidance of CEUS is expected to yield decreased non-diagnostic result. The investigators intent to create a randomized controlled study to investigate the application value of CEUS in the diagnosis of space-occupying lesions of the thyroid using FNA.

研究设计

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

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

  • Patients with a space-occupying thyroid lesion found either via conventional ultrasound or CT/MRI and clinically requiring a further biopsy.
  • Age 18 years old or above with no limitation of gender.
  • Obtain a signed informed consent.

排除标准

  • Contraindications to the use of contrast agents as described by the medication guide.
  • Patients who are contraindicated to aspiration biopsy: patients with unexplained bleeding history, severe anemia, or patients who have a tendency to bleed and this bleeding disorder has not been corrected (prothrombin time 3-5seconds longer than the normal control, platelet count <60000/mm3); no safe aspiration path; menstruating female patients.
  • If the patient has a serious psychological or mental problem, and is suspected to have a poor compliance with the current clinical study, or maybe unable to obtain a definitive diagnosis for the lesion.
  • Pregnant or lactating women or women with a positive pregnancy test before their first medications are given.

结局指标

主要结局

The Bethesda System for Reporting Thyroid Cytology (TBSRTC)

时间窗: From date of randomization until the date of first documented cytopathology result of fine needle aspiration (FNA) on the suspected nodule, assessed up to 1 month

To evaluate contrast-enhanced ultrasound (CEUS) improving the technical sufficiency of fine needle aspiration (FNA). The Bethesda System for Reporting Thyroid Cytology (TBSRTC) has six general diagnostic categories. Each of the categories has an implied cancer risk (ranging from 0 to 3% for the benign category to nearly 100% for the malignant category) with rational clinical management guidelines.

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

Ying Fu

Principal Investigator

Peking University Third Hospital

研究点 (1)

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