ClinicalTrials.Veeva

Menu

Comparison of Real-time and Shear Wave Elastography

University Hospital Basel logo

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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems