Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1080 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. The primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline screening mammography recall rates in negative examinations by at least 20%.

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Detailed Description

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The FFDM images and the FFDM images with the DBT images will be interpreted independently by two experienced radiologists under standard clinical screening procedures. Recommended recall rates will be assessed and compared as a result of each of the two interpretations.

Conditions

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Breast Abnormalities

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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tomosynthesis and screening mammography

All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.

Intervention Type DEVICE

Other Intervention Names

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digital breast tomosynthesis

Eligibility Criteria

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Inclusion Criteria

* Women between the ages of 34 and 56.
* Women presenting for their baseline screening mammography examination

Exclusion Criteria

* Women with a palpable finding(s) via a Breast Self Examination (BSE) or Clinical Breast Examination (CBE).
* Women who may be or are pregnant by self report
* Women older than 55 years of age or younger than 35.
* Women with known fatty breast tissue
* Males and children
* Women who are unable to understand or execute written informed consent

Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes