Identification and Differentiation of Thyroid Nodules by Acoustic Imaging and Viscoelastic Parameters
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 650
- 试验地点
- 3
- 主要终点
- Specificity of VA in differentiating malignant and benign of thyroid nodules
研究概览
简要总结
This study is being done to identify and differentiate thyroid nodules by acoustic imaging and viscoelastic parameters.
详细描述
PRIMARY OBJECTIVES:
I. Identification of thyroid nodules by vibro-acoustography - Determine detection rate.
II. Evaluate the specificity of VA in differentiating malignant and benign of thyroid nodules - Compare the result to that of ultrasound (US).
III. Assess diagnostic value of Shear Wave Ultrasound Vibrometry (SDUV) and Comb Push shear elastography (CUSE) in differentiation of thyroid nodules - correlate SDUV and CUSE results to pathology.
IV. Test and compare the results shear wave imaging with new FDA approved ultrasound device called SuperSonic Imagine Aixplorer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •* Male and female patient volunteers ages 8 and up who are suspicious for thyroid cancer
- •Patients who have palpable and sonographically detectable lymph nodes or nonthyroidal neck masses and are referred to Radiology Department or Endocrinology for fine-needle aspiration biopsy (FNAB)
- •Patients 18 and up who were previously diagnosed with thyroid cancer and treated with thyroidectomy and recently diagnosed as having recurrence nodes on thyroid bed or on their neck
排除标准
- •Because thyroid cancer is rare under the age of 8 years, children younger than this age are excluded from the study
- •Having FNAB or surgical biopsy on thyroid in less than two weeks for thyroid nodule detection group
- •Having FNAB or surgical biopsy on cervical lymph nodes or non- thyroidal masses for this group of patients
结局指标
主要结局
Specificity of VA in differentiating malignant and benign of thyroid nodules
时间窗: Baseline, 3 months post ablation, 6 months post ablation, 12 months post ablation
Specificity of VA in differentiating malignant and benign of thyroid nodules will be determined by comparing the VA image to the US image.
Incidence of nodules successfully sited by vibro-acoustography (VA)
时间窗: Baseline, 3 months post ablation, 6 months post ablation, 12 months post ablation
Successful nodule localization will be assessed by the review of the VA image relative to the nodule location information from the reference ultrasound (US) image (agree/disagree on location will be determined for each nodule).
次要结局
未报告次要终点