Comparative Study of B-mode Ultrasound, Sono-Elastography, and Diffusion-weighted Imaging MRI in the Characterization of Thyroid Nodules
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- compare findings of ultrasound, elastography values , ADC value with the gold standard (biopsy results)
研究概览
简要总结
To compare the accuracy of the conventional Ultrasound 'TI-RADS', US elastography, DWI MRI, and its ADC value in characterization and differentiation of thyroid nodules.
详细描述
Thyroid nodules are one of the most common endocrine carcinomata (1) Most thyroid tumors have a good prognosis if early diagnosis and timely treated (2) An Ultrasound (US) exam is a safe, non-invasive imaging technique for detecting thyroid nodules (3) However, still there are no dependable criteria to discriminate malignant from benign lesions. (4) In 2009, Horvath et al proposed the Thyroid Imaging Report and Data System (TI-RADS). The new version of TI-RADS was launched by ACR in 2017. (5) Color Doppler ultrasound is also used to differentiate benign from malignant thyroid nodules. The presence of intra-nodular vascularity (Type 1b) was considered close to be malignant (6) US elastography is a novel tool to increase the diagnostic value of Ultrasound and as an adjuvant tool (7) Shear wave elastography evaluates elasticity through the propagation speed of shear waves, with the wave speed being faster in hard tissue (8) Conventional T1-and T2-weighted MR imaging can-not differentiate benign from malignant nodules (9) Diffusion-weighted imaging (DWI) is a non-invasive tool used to distinguish benign from malignant nodules (10). Malignant thyroid nodules usually have a lower ADC value attributed to cellular density and tissue perfusion. (11) Combining subjective MRI features with a quantitative measurement could improve the diagnostic yield of DW-MRI (12) The cytological examination by fine-needle aspiration (FNA) has become a reliable tool to diagnose thyroid cancers (2) Suspicious cytological findings reach up to 30% of all aspirated nodules, suggesting the need for less invasive methods (13)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should have a normal bleeding profile.
- •Presence of solitary or multiple nodules in the thyroid gland.
- •In the case of patients having multiple nodules, the nodule having suspicious ultrasound features (having TI-RADS score 4 or 5) was selected for further analysis.
- •The nodules were either solid or mixed (containing both solid and cystic parts) with a predominant solid component
排除标准
- •Contraindicated biopsy (as thrombocytopenia or bleeding disorder).
- •Patient with cystic and mainly cystic nodules (TI-RADS 1 nodules).
- •Nodules with complete shell-calcification which may cause color mapping artifacts.
- •MRI contraindications such as Claustrophobia, MR-incompatible pacemakers, and MR-incompatible prosthetic heart valves.
- •Patients with recurrent thyroid masses.
- •History of operative procedure, chemo, or radiotherapy on the thyroid gland.
- •Declined consent.
结局指标
主要结局
compare findings of ultrasound, elastography values , ADC value with the gold standard (biopsy results)
时间窗: 1 year
To assess concordance of US suspicious features, US elastography results , MRI DWI, ADC value results, and the gold standard US-guided FNAB and ability to differentiate benign from malignant thyroid nodules.
次要结局
- Study role of color doppler in differentiating benign from malignant thyroid nodules(1 year)
- Apply ADC value Cut-off level to differentiate benign from malignant thyroid nodules(1 year)
- Apply US shear elastography parameters Cut-off levels to differentiate benign from malignant thyroid nodules.(1 year)
- Compare individual specific US features with the Gold standard US-guided FNAB which is more important.(1 year)
- Compare the added value of combining different modalities, which have the higher sensitivity and specificity in differentiating benign from malignant thyroid nodules(1 year)
研究者
Salma Ahmed Ragheb
assistant lecturer, Luxor university
Assiut University