Comparison of Real-time and Shear Wave Elastography

Breast Diseases Clinical Trial

— Elasto  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487471
• Other study ID #: Elasto Trial
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 18, 2023

Study information

• Verified date: May 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 18, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Diseases

Intervention

Diagnostic Test:
• Real-time elastography
Breast ultrasound with real-time elastography
• Shear wave elastography
Breast ultrasound with shear wave elastography

Locations

Country	Name	City	State
Switzerland	St Claraspital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Examinators learning curve	Establish learning curves for real-time elastography and shear wave elastography	baseline until year 1