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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1494 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-23

Study Completion Date

2023-01-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Screening

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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women scheduled for breast screening

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.

DBT (Full field digital mammography + tomosynthesis)

Intervention Type PROCEDURE

breast ultrasound

Intervention Type PROCEDURE

Interventions

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DBT (Full field digital mammography + tomosynthesis)

Intervention Type PROCEDURE

breast ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No