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

Completed

• Conditions: Breast Screening
• Interventions: Procedure: breast ultrasound; Procedure: DBT (Full field digital mammography + tomosynthesis)

• Registration Number: NCT02174406
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-23
• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-25
• Status Verified: 2023-01
• Primary Completion: 2023-01-19
• Study Completion: 2023-01-19
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1494

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
women scheduled for breast screening	breast ultrasound	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.
women scheduled for breast screening	DBT (Full field digital mammography + tomosynthesis)	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.

Primary Outcome Measures

Name	Time	Method
estimate the cancer detection rates	2 years	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).

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States