Clinical Trials Directory

Trials / Completed

CompletedNCT06191926

Diagnostic Performance of Shear Wave Dispersive Imaging in Breast Lesions: Comparison With Shear Wave Elastography

Diagnostic Performance of Shear Wave Dispersive Imaging to Differenciate Benign From Malignant Breast Lesions: Comparison With Shear Wave Elastography

Status
Completed
Phase
Study type
Observational
Enrollment
594 (actual)
Sponsor
Korea University Ansan Hospital · Academic / Other
Sex
Female
Age
20 Years – 90 Years
Healthy volunteers
Not accepted

Summary

Human soft tissue such as breast tissue has viscoelasticity property. However, most ultrasound has only been measured for elasticity and viscosity has been neglected. Shear wave elastography (SWE) is a ultrasound technique that quantifies tissue elasticity. Shear wave dispersion (SWD) imaging is a newly developed ultrasound technique that evaluates the dispersion slope of shear waves, which is related to the viscosity of biological tissues. The goal of this retrospective study was to compare diagnostic performance between SWE and SWD to distinguish benign from malignant breast masses and to investigate additional role of SWD. Using histological diagnosis of breast lesions as a standard reference, quantitative indices of SWE and SWD were evaluated to diagnose breast cancer, and the diagnostic performance of SWE and SWD was compared.

Detailed description

This retrospective study was approved by our institutional review board, which waved the requrement for informed consent. The investigators obtained quantitative parameters of SWE and SWD of solid breast lesions before biopsy. The investigators measured average tumor elasticity and tumor-to-fat elasticity ratio on SWE and average tumor dispersion and tumor-to-fat ratio and on SWD from each breast lesion. Diagnostic performance of SWE and SWD was compared using the area under the curve (AUC), sensitivity, specificity, and accuracy.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTultrasoundShear-wave elastography and shear-wave dispersion ultrasound to evaluate the diagnostic performance of solid breast lesions for the diagnosis of breast cancer

Timeline

Start date
2020-08-01
Primary completion
2021-08-31
Completion
2023-11-30
First posted
2024-01-05
Last updated
2024-01-08

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT06191926. Inclusion in this directory is not an endorsement.