Abstract：
OBJECTIVE: To evaluate the diagnostic performance of contrast-enhanced (CE) ultrasound using Sonazoid (SNZ-CEUS) by comparing with contrast-enhanced computed tomography (CE-CT) and contrast-enhanced magnetic resonance imaging (CE-MRI) for differentiating benign and malignant renal masses.
METHODS: 306 consecutive patients (from 7 centers) with renal masses (40 benign tumors, 266 malignant tumors) diagnosed by both SNZ-CEUS, CE-CT or CE-MRI were enrolled between September 2020 and February 2021. The examinations were performed within 7 days, but the sequence was not fixed. Histologic results were available for 301 of 306 (98.37%) lesions and 5 lesions were considered benign after at least 2 year follow-up without change in size and image characteristics. The diagnostic performances were evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and compared by McNemar\'s test.
RESULTS: In the head-to-head comparison, SNZ-CEUS and CE-MRI had comparable sensitivity (95.60 vs. 94.51%, P = 0.997), specificity (65.22 vs. 73.91%, P = 0.752), positive predictive value (91.58 vs. 93.48%) and negative predictive value (78.95 vs. 77.27%); SNZ-CEUS and CE-CT showed similar sensitivity (97.31 vs. 96.24%, P = 0.724); however, SNZ-CEUS had relatively lower than specificity than CE-CT (59.09 vs. 68.18%, P = 0.683). For nodules > 4 cm, CE-MRI demonstrated higher specificity than SNZ-CEUS (90.91 vs. 72.73%, P = 0.617) without compromise the sensitivity.
CONCLUSIONS: SNZ-CEUS, CE-CT, and CE-MRI demonstrate desirable and comparable sensitivity for the differentiation of renal mass. However, the specificity of all three imaging modalities is not satisfactory. SNZ-CEUS may be a suitable alternative modality for patients with renal dysfunction and those allergic to gadolinium or iodine-based agents.
METHODS: 306 consecutive patients (from 7 centers) with renal masses (40 benign tumors, 266 malignant tumors) diagnosed by both SNZ-CEUS, CE-CT or CE-MRI were enrolled between September 2020 and February 2021. The examinations were performed within 7 days, but the sequence was not fixed. Histologic results were available for 301 of 306 (98.37%) lesions and 5 lesions were considered benign after at least 2 year follow-up without change in size and image characteristics. The diagnostic performances were evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and compared by McNemar\'s test.
RESULTS: In the head-to-head comparison, SNZ-CEUS and CE-MRI had comparable sensitivity (95.60 vs. 94.51%, P = 0.997), specificity (65.22 vs. 73.91%, P = 0.752), positive predictive value (91.58 vs. 93.48%) and negative predictive value (78.95 vs. 77.27%); SNZ-CEUS and CE-CT showed similar sensitivity (97.31 vs. 96.24%, P = 0.724); however, SNZ-CEUS had relatively lower than specificity than CE-CT (59.09 vs. 68.18%, P = 0.683). For nodules > 4 cm, CE-MRI demonstrated higher specificity than SNZ-CEUS (90.91 vs. 72.73%, P = 0.617) without compromise the sensitivity.
CONCLUSIONS: SNZ-CEUS, CE-CT, and CE-MRI demonstrate desirable and comparable sensitivity for the differentiation of renal mass. However, the specificity of all three imaging modalities is not satisfactory. SNZ-CEUS may be a suitable alternative modality for patients with renal dysfunction and those allergic to gadolinium or iodine-based agents.
摘要：
目的：通过与对比增强计算机断层扫描（CE-CT）和对比增强磁共振成像（CE-MRI）比较，评估Sonazoid对比增强（CE）超声（SNZ-CEUS）对肾脏良恶性肿块的诊断性能。
方法：306例（来自7个中心）肾肿块（40例良性肿瘤，266个恶性肿瘤）由SNZ-CEUS诊断，CE-CT或CE-MRI在2020年9月至2021年2月期间入选。检查在7天内进行，但顺序不是固定的。306个病变中有301个（98.37％）的组织学结果可用，经过至少2年的随访，5个病变被认为是良性的，而大小和图像特征没有变化。通过灵敏度评估诊断性能，特异性，正预测值，负预测值，并通过McNemar的测试进行了比较。
结果：在头对头比较中，SNZ-CEUS和CE-MRI的敏感性相当（95.60vs.94.51%,P=0.997),特异性（65.22vs.73.91%,P=0.752),阳性预测值（91.58vs.93.48%）和阴性预测值（78.95vs.77.27%)；SNZ-CEUS和CE-CT的敏感性相似(97.31vs.96.24%,P=0.724)；然而，SNZ-CEUS的特异性相对低于CE-CT（59.09vs.68.18%,P=0.683)。对于>4厘米的结节，CE-MRI表现出比SNZ-CEUS更高的特异性（90.91vs.72.73%,P=0.617)而不损害灵敏度。
结论：SNZ-CEUS，CE-CT,和CE-MRI对肾脏肿块的鉴别具有理想且相当的敏感性。然而,所有三种成像方式的特异性均不令人满意.SNZ-CEUS可能是肾功能不全患者以及对钆或碘类药物过敏的患者的合适替代方式。
方法：306例（来自7个中心）肾肿块（40例良性肿瘤，266个恶性肿瘤）由SNZ-CEUS诊断，CE-CT或CE-MRI在2020年9月至2021年2月期间入选。检查在7天内进行，但顺序不是固定的。306个病变中有301个（98.37％）的组织学结果可用，经过至少2年的随访，5个病变被认为是良性的，而大小和图像特征没有变化。通过灵敏度评估诊断性能，特异性，正预测值，负预测值，并通过McNemar的测试进行了比较。
结果：在头对头比较中，SNZ-CEUS和CE-MRI的敏感性相当（95.60vs.94.51%,P=0.997),特异性（65.22vs.73.91%,P=0.752),阳性预测值（91.58vs.93.48%）和阴性预测值（78.95vs.77.27%)；SNZ-CEUS和CE-CT的敏感性相似(97.31vs.96.24%,P=0.724)；然而，SNZ-CEUS的特异性相对低于CE-CT（59.09vs.68.18%,P=0.683)。对于>4厘米的结节，CE-MRI表现出比SNZ-CEUS更高的特异性（90.91vs.72.73%,P=0.617)而不损害灵敏度。
结论：SNZ-CEUS，CE-CT,和CE-MRI对肾脏肿块的鉴别具有理想且相当的敏感性。然而,所有三种成像方式的特异性均不令人满意.SNZ-CEUS可能是肾功能不全患者以及对钆或碘类药物过敏的患者的合适替代方式。
