ShearWave™ Elastography of Breast Lesions in Chinese Patients (BE3)

Supersonic Imagine

Status: Completed

Conditions: Breast Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT02226081

BE3

ChiCTR-DDT-14004785 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,273 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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