Comparison of Real-time and Shear Wave Elastography

Not Applicable

Completed

• Conditions: Breast Diseases

• Registration Number: NCT03487471
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-04
• Primary Completion: 2021-12-31
• Status Verified: 2023-05
• Study Completion: 2023-12-18
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Examinators learning curve	baseline until year 1	Establish learning curves for real-time elastography and shear wave elastography

Trial Locations

Locations (1)

St Claraspital; 🇨🇭 Basel, Switzerland