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

Memorial Sloan Kettering Cancer Center1,494 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,494

Conditions

Breast Screening

Interventions

breast ultrasoundPROCEDURE

DBT (Full field digital mammography + tomosynthesis)PROCEDURE

Eligibility

Sex: FEMALEMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

estimate the cancer detection rates

The detection rate of each imaging test is defined as the proportion of patients who are positive on that imaging test who truly have the disease compared to the total number of women screened. A positive imaging test is defined as a test with a recommendation for biopsy (BI-RADS 4 or 5).

Time frame: 2 years

Data from ClinicalTrials.gov

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