Comparison of Real-time and Shear Wave Elastography

Study Overview
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Brief Summary
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Tissue elasticity is being increasingly used as diagnostic parameter, since at the macroscopic level benign breast lesions tend to be stiffer than normal breast tissue but softer than breast cancers. Ultrasound elastography allows to probe the elasticity of breast lesions in clinics. Real time elastography (RTE) and shear wave elastography (SWE) are the two most widely used elastography modalities. Assessment of breast lesions by either RTE or SWE improve the diagnostic performance of standard B-mode ultrasound (US) and have the potential to assist the decision about whether to perform a breast biopsy or not.

Detailed Description
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Tissue elasticity is being increasingly used as diagnostic parameter, since at the macroscopic level benign breast lesions tend to be stiffer than normal breast tissue but softer than breast cancers. Ultrasound elastography allows to probe the elasticity of breast lesions in clinics. Real time elastography (RTE) and shear wave elastography (SWE) are the two most widely used elastography modalities. Assessment of breast lesions by either RTE or SWE improve the diagnostic performance of standard B-mode ultrasound (US) and have the potential to assist the decision about whether to perform a breast biopsy or not. However, employing RTE and SWE using the same equipment to directly compare elasticity measurements of a breast lesion has not been done. Investigators propose to prospectively investigate inter-observer agreement of each modality. The study will investigate and compare the accuracy and reproducibility of SWE and RTE in the characterization of breast lesions. Furthermore, we plan to establish learning curves for RTE and SWE. In this project, investigators will compare RTE and SWE concerning their potential to discriminate benign breast lesions from breast cancer. Investigators aim is to identify which modality will allow clinicians the best possible patient care.

Official Title
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Comparison of Accuracy and Reproducibility of Breast Lesion Characterization Between Real Time Elastography and Shear Wave Elastography

Conditions
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Breast Diseases

Intervention / Treatment
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* Diagnostic Test: Real-time elastography
* Diagnostic Test: Shear wave elastography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients at least 18 years of age with a known breast lesion Signed informed consent Exclusion Criteria: Male Younger than 18 years of age Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real-time elastography<br>98 patients with breast lesion will a receive breast ultrasound (real time elastography) | Diagnostic Test: Real-time elastography<br>* Breast ultrasound with real-time elastography<br>|
| Active Comparator: Shear Wave<br>98 patients with breast lesion will a receive breast ultrasound (shear wave elastography) | Diagnostic Test: Shear wave elastography<br>* Breast ultrasound with shear wave elastography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of dignity of breast lesion by use of real-time elastography | variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography | at baseline | 
| assessment of dignity of breast lesion by use of shear wave elastography | variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examinators learning curve | Establish learning curves for real-time elastography and shear wave elastography | baseline until year 1 |