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临床试验/NCT03276845
NCT03276845已完成不适用

Multiparametric High-resolution 3-D Sonography With Color/Power-Doppler, Elastography and Contrast-enhanced Sonography for an Improved Detection and Characterization of Breast Tumors

Medical University of Vienna0 个研究点目标入组 124 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
124
主要终点
Diagnostic accuracy (sensitivity, specificity, area under the receiver operating characteristic-ROC curve)

研究概览

简要总结

Despite advances in mammographic technique, mammography is limited in the detection and diagnosis of breast lesions with respect to sensitivity and specificity. In recent decades, ultrasound has become an essential adjunct to mammography for the further characterization of mammographically detected or palpable lesions or in the diagnosis of patients with dense breasts.

However, in spite of defined morphological criteria for the differentiation of benign from malignant lesions, ultrasound of the breast also shows limitations regarding sensitivity and specificity. On the one hand, benign lesions may have one or more malignant characteristics and thus require a biopsy. On the other hand, malignant lesions can also show benign characteristics and thus make an accurate assessment difficult.

To overcome these limitations, newer sonographic methods have been developed. These include elastography, color and power Doppler imaging, contrast enhanced imaging and 3D sonography.

The application of elastography is based on the fact that cancer has a higher stiffness than healthy breast parenchyma.

In addition, cancers are characterized by neoangiogenesis and thus generally show an increased vascularization in color and power Doppler. The detection of neoangiogenesis can be improved by the application of contrast agents. The latter provides both morphological and functional information about tumors, through the study of the contrast agent kinetics.

Finally, 3D sonography allows for tumors to be examined in a third, coronal plane. This way, the interaction between the tumor and the surrounding healthy tissue can be better appreciated.

The objective of this study is the evaluation of suspicious (classified as BI-RADS 4 and 5) breast lesions by using high-resolution sonography, including elastography, color/power Doppler, contrast agent application and 3D sonography. Both morphological and functional information can thus be obtained. The primary hypothesis of this study is that this multiparametric approach will improve the detection and characterization of breast lesions.

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical, mammographic, MR-tomographic and/or ultrasonographic verification of a suspicious breast lesion (BIRADS 4 and 5)
  • Age > 18 years
  • Written informed consent
  • Histopathological verification of the lesions either by core biopsy or by surgical excision

排除标准

  • Unstable or non-compliant patients
  • Pregnant or lactating patients or patients with suspected pregnancy
  • Known contraindication to the intravenous administration of US contrast agents
  • Acute or chronic renal insufficiency
  • Pre- or post-transplant patients

研究组 & 干预措施

1

Other

干预措施: Ultrasound of the breast (Diagnostic Test)

结局指标

主要结局

Diagnostic accuracy (sensitivity, specificity, area under the receiver operating characteristic-ROC curve)

时间窗: 2 years

H0: There is no difference in diagnostic accuracy of breast ultrasound through the addition of further sonographic techniques. H1: There is a difference in diagnostic accuracy of breast ultrasound through the addition of further sonographic techniques.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Panagiotis Kapetas

M.D.

Medical University of Vienna

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