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NCT06191926 Clinical Trial

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

Breast Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06191926
Other study ID # DispersionUS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date November 30, 2023

Study information
Verified date January 2024
Source Korea University Ansan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 594
Est. completion date November 30, 2023
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria: - patients with histological results Exclusion Criteria: - patients without histological results

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• ultrasound
Shear-wave elastography and shear-wave dispersion ultrasound to evaluate the diagnostic performance of solid breast lesions for the diagnosis of breast cancer

Locations
Country Name City State
Korea, Republic of Bo Kyoung Seo Ansan

Sponsors (1)
Lead Sponsor Collaborator
Korea University Ansan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Elastography and dispersion parameters to determine benign or malignant tumors The elastography and dispersion ultrasound parameter values correlated with histological results. baseline, pre-biopsy
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