NCT06191926

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
594

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

December 20, 2023

Last Update Submit

January 4, 2024

Conditions

Breast Diseases

Outcome Measures

Primary Outcomes (1)

  • Elastography and dispersion parameters to determine benign or malignant tumors

    The elastography and dispersion ultrasound parameter values correlated with histological results.

    baseline, pre-biopsy

Interventions

ultrasoundDIAGNOSTIC_TEST

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

Eligibility Criteria

Age20 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • patients with histological results

You may not qualify if:

  • patients without histological results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bo Kyoung Seo

Ansan, 15355, South Korea

Location

MeSH Terms

Conditions

Breast Diseases

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Bo Kyoung Seo, MD, PhD

    Korea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2023

First Posted

January 5, 2024

Study Start

August 1, 2020

Primary Completion

August 31, 2021

Study Completion

November 30, 2023

Last Updated

January 8, 2024

Record last verified: 2024-01

Locations

KR(1)