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OpenTrials
Completed

NCT Number: NCT01106911

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

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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Key information

Conditions

Breast Abnormalities

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tomosynthesis and screening mammography

Device

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

Other names: digital breast tomosynthesis

Primary outcomes

  1. Number of Participants Without Cancer Who Were Recalled

    Time frame: upon recruitment/enrollment phase completion

    Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study

Important dates

Study start
2010
Primary completion
2014
First posted
Apr 20, 2010
Registry last updated
Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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