Breast Diseases
Conditions
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.
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.
Interventions
DIAGNOSTIC_TESTReal-time elastography
Breast ultrasound with real-time elastography
DIAGNOSTIC_TESTShear wave elastography
Breast ultrasound with shear wave elastography
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Examinators learning curve | baseline until year 1 | Establish learning curves for real-time elastography and shear wave elastography |
Countries
Switzerland
Outcome results
None listed