Breast Cancer Clinical Trial

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

Summary

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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Full Description

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.

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Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

1080

Study ID:

NCT01106911

Recruitment Status:

Completed

Sponsor:

University of Pittsburgh

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There is 1 Location for this study

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Magee-Womens Hospital
Pittsburgh Pennsylvania, 15213, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

1080

Study ID:

NCT01106911

Recruitment Status:

Completed

Sponsor:


University of Pittsburgh

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