Multiparametric High-resolution Ultrasound of the Breast

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Ultrasound of the breast

• Registration Number: NCT03276845
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2017-04
• Status Verified: 2017-09
• Study Completion: 2017-09
• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-07
• Last Update Submitted: 2017-09-07
• Study First Posted: 2017-09-08
• Last Update Posted: 2017-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Ultrasound of the breast	-

Primary Outcome Measures

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