Utility of Contrast-Enhanced Sonography and Shear Wave Elastography in Conjunction With ACR TI-RADS for the Evaluation of Thyroid Nodules
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Agreement: 1) between two radiologists for visually assessed CEUS result and 2) between the radiologists reconciled visual assessment result and the gold standard result (biopsy).
研究概览
简要总结
Our overall hypothesis is that Contrast-enhanced ultrasound (CEUS) and Shear Wave Elastography (SWE) will allow for high diagnostic accuracy of benign and malignant thyroid nodules, which will correlate with and complement the ACR TI-RADS classification system, allowing for more accurate diagnosis of benign and malignant thyroid nodules.
详细描述
Thyroid nodules are an exceedingly common clinical entity, however, only a small percentage of nodules are malignant. Conventional ultrasound is the current standard for the initial evaluation of thyroid nodules, yet due to several overlapping characteristics between benign and malignant nodules its utility in diagnosis has been limited, leading to a high rate of negative biopsies. To overcome these challenges the American College of Radiology has proposed a Thyroid Imaging Reporting and Data System (TI-RADS) in an effort to decrease unnecessary biopsies [5]. While these efforts have shown encouraging results, further work is still needed. Contrast-enhanced ultrasound (CEUS) and Shear Wave Elastography (SWE) are two emerging non-invasive imaging techniques which have shown promising results in the evaluation of thyroid nodules. However, data is limited and how these imaging modalities could potentially compliment ACR TI-RADS is unknown.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients over the age of 18 with one or more thyroid nodules diagnosed on conventional ultrasound within the last 6 months.
- •Patients referred for standard of care thyroid nodule biopsy, ordered at the discretion of the treating physician and/or radiologists.
- •Patients must demonstrate ability to understand and express willingness to sign a written informed consent to undergo SWE and CEUS imaging prior to their thyroid nodule biopsy.
排除标准
- •Patients who are pregnant, nursing, or less than 18 years of age
- •Thyroid nodules ≤1 cm
研究组 & 干预措施
CEUS and SWE
CEUS & SWE
干预措施: Contrast-enhanced ultrasound (Other)
CEUS and SWE
CEUS & SWE
干预措施: Shear Wave Elastography (Other)
CEUS and SWE
CEUS & SWE
干预措施: Sequoia System (Device)
结局指标
主要结局
Agreement: 1) between two radiologists for visually assessed CEUS result and 2) between the radiologists reconciled visual assessment result and the gold standard result (biopsy).
时间窗: 8 months
Kappa analysis will be used to assess the agreement between the two radiologists visual assessment result. The rating result of each radiologist will be compared to the pathological result using Kappa analysis as well.
次要结局
- Agreement between the statistical model predicted result using quantitative metrics from CEUS and/or SWE and the gold standard result (biopsy).(12 months)
研究者
Edward Grant
Professor
University of Southern California