Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Screening

Treatments: Procedure: DBT (Full field digital mammography + tomosynthesis); Procedure: breast ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT02174406

14-119

Details and patient eligibility

About

The purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and DBT.

Enrollment: 1,494 patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other.

Exclusion criteria

• Age < 30 years old
• Male patients
• Patients with any clinical symptoms (palpable mass, nipple discharge, etc)
• Patients with known cancer
• Patients with any breast surgery or biopsy within 90 days prior to the study
• Patients with breast implants
• Patients pregnant or lactating

Trial design

1,494 participants in 1 patient group

women scheduled for breast screening

Description:

Each patient will have the following: * Screening whole breast ultrasound * DBT (Full field digital mammography + tomosynthesis views in the CC and MLO projections). The only change in patient management will be the addition of digital breast tomosynthesis views in patients scheduled for FFDM alone. DBT is currently clinically approved and being offered on a voluntary basis to patients scheduled for FFDM.

Treatment:

Procedure: DBT (Full field digital mammography + tomosynthesis)

Procedure: breast ultrasound