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OpenTrials
Completed

NCT Number: NCT03487471

Comparison of Real-time and Shear Wave Elastography

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St Claraspital

Basel, 4016, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real-time elastography

Diagnostic Test

Breast ultrasound with real-time elastography

Shear Wave Elastography

Diagnostic Test

Breast ultrasound with shear wave elastography

Primary outcomes

  1. assessment of dignity of breast lesion by use of real-time elastography

    Time frame: at baseline

    variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography

  2. assessment of dignity of breast lesion by use of shear wave elastography

    Time frame: at baseline

    variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography

Secondary outcomes

  1. Examinators learning curve

    Time frame: baseline until year 1

    Establish learning curves for real-time elastography and shear wave elastography

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: Elasto

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Apr 4, 2018
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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