Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 602
- 试验地点
- 10
- 主要终点
- Realtime-Elastography scores I-IV in thyroid nodules
研究概览
简要总结
The study is an open, prospective multicenter study. According to the statistical sample size calculation 593 patients with thyroid nodules ≥ 5mm in size will be included in the study. Reference methods are cytology obtained by Fine needle aspiration biopsy (FNAB) or histology obtained by surgery.
All patients will receive an B-mode and Duplex ultrasound examination of the thyroid gland, as well as Realtime Elastography of thyroid nodules.
Results of B-mode and Duplex ultrasound are compared to Realtime Elastography to evaluate the additional value of Realtime Elastography in the diagnostic work up of thyroid nodules.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with thyroid nodules ≥ 5mm in size and TSH ≥ 0,35µU/ml
- •Cytology obtained by FNAB or thyroid surgery planned
- •age ≥ 18 year
- •signed written consent
排除标准
- •Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
- •Non-contractually capable persons
- •Pregnancy
- •Lactation
结局指标
主要结局
Realtime-Elastography scores I-IV in thyroid nodules
Scores: I-II: benign; III-IV: malignant nodules. The sensitivity and specificity of Realtime-Elastography for the diagnosis of malignant thyroid nodules will be calculated on the basis of above-specified criteria. Cytology is used as reference method for benign nodules and histology for malignant nodules.
次要结局
- Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography
研究者
Johannes Vermehren
Record Keeper
Johann Wolfgang Goethe University Hospital