Comparison of Real-time and Shear Wave Elastography

University Hospital Basel

Status: Completed

Conditions: Breast Diseases

Treatments: Diagnostic Test: Real-time elastography; Diagnostic Test: Shear wave elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT03487471

Elasto Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Real-time elastography

Active Comparator group

Description:

98 patients with breast lesion will a receive breast ultrasound (real time elastography)

Treatment:

Diagnostic Test: Real-time elastography

Shear Wave

Active Comparator group

Description:

98 patients with breast lesion will a receive breast ultrasound (shear wave elastography)

Treatment:

Diagnostic Test: Shear wave elastography