Comparison of Real-time and Shear Wave Elastography
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Real-time elastography 98 patients with breast lesion will a receive breast ultrasound (real time elastography) |
Diagnostic Test: Real-time elastography
Breast ultrasound with real-time elastography
|
| Active Comparator: Shear Wave 98 patients with breast lesion will a receive breast ultrasound (shear wave elastography) |
Diagnostic Test: Shear wave elastography
Breast ultrasound with shear wave elastography
|
Outcome Measures
Primary Outcome Measures
- assessment of dignity of breast lesion by use of real-time elastography [at baseline]
variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography
- assessment of dignity of breast lesion by use of shear wave elastography [at baseline]
variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography
Secondary Outcome Measures
- Examinators learning curve [baseline until year 1]
Establish learning curves for real-time elastography and shear wave elastography
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female patients at least 18 years of age with a known breast lesion
-
Signed informed consent
Exclusion Criteria:
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Male
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Younger than 18 years of age
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Pregnant or lactating women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St Claraspital | Basel | Switzerland | 4016 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
Investigators
- Principal Investigator: Rosanna Zanetti, St Claraspital Basel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Elasto Trial