Ultrasound Elastography of Breast Lesions (BE1)

Supersonic Imagine

Status: Completed

Conditions: Breast Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT00716482

A00152-53

Details and patient eligibility

About

Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast ultrasound examination provides useful information for the radiologist when imaging lesions in the breast, as compared to conventional grayscale ultrasound alone.

Enrollment: 1,681 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who have been referred to a breast ultrasound because of a positive physical palpation and/or positive mammograms and/or positive ultrasound and/or positive MRI.
• female
• age 21 or older
• provide informed consent

Exclusion criteria

• Women who are unwilling or unable to provide informed consent
• Women with breast implants
• Women with superficial lesions or lesions on skin (with the most superficial surface of the lesion within 5 mm of the skin surface)
• Women who are pregnant or breastfeeding
• Women who are undergoing chemotherapy or radiotherapy for any cancer
• Women with previous breast conserving surgery on the breast of interest Note: Previous excision of a benign lesion 4 cm or more away from the suspected lesion does not constitute an exclusion criterion.