ShearWave™ Elastography of Breast Lesions in Chinese Patients

Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02226081

Acronym

BE3

Enrollment

2273

Registered

2014-08-26

Start date

2014-06-30

Completion date

2015-06-30

Last updated

2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

breast lesion, ultrasound, BI-RADS, women, malignancy

Brief summary

We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions.

Detailed description

Chinese women are known to have denser breasts than women in Western countries. Mammography cannot find abnormalities easily in denser breasts, while breast ultrasound is not affected by density. Adding elastography, a stiffness measurement, to a breast ultrasound exam should improve the diagnosis of a lesion.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* female * 18 years of age or older * known breast lesion that has not been managed or treated * referred for a breast ultrasound because of a breast mass found on at least one of the following examinations: * physical palpation * mammography * ultrasound exam * MRI

Exclusion criteria

* Women who are unwilling or unable to provide informed consent * Women with breast implants * Women who are pregnant or breastfeeding * Women in whom all lesions are diagnostically categorized as BI-RADS 0, 1 or 6 * Women with previous ipsilateral breast surgery * Women with no visible breast mass on ultrasound examination * Women with axillary metastatic lymph nodes only * Women with foreign body in the breast * Women who are not Chinese nationality

Design outcomes

Primary

Measure	Time frame
Increase in specificity of breast ultrasound imaging when considering stiffness measurements	Within 18 months of the study start date

Secondary

Measure	Time frame
Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements	Within 18 months of the study start date
Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements	within 18 months of the study start date

Countries

China

Outcome results