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

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.

Study Overview

• Status: Completed
• Conditions: Breast Diseases
• Intervention / Treatment: Diagnostic test: ultrasound

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.

• Study Type: Observational
• Enrollment (Actual): 594

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of, 15355
    • Bo Kyoung Seo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population should fulfill the following criteria as follows:(a) histologically confirmed breast lesions and (b) shear wave elastography and dispersion ultrasound performed before biopsy

Description

Inclusion Criteria:

• patients with histological results

Exclusion Criteria:

• patients without histological results

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Korea University Ansan Hospital
• Investigators: Principal Investigator: Bo Kyoung Seo, MD, PhD, Korea University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases
• Other Study ID Numbers: DispersionUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No